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Conclusions: Guidelines for implementing the use of psychedelic medicines

January 2007

Authors:

Michael James Winkelman

Arizona State University

.1 Phases of Evaluation of Psychedelic Medicines

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CONCLUSIONS: GUIDELINES FOR

IMPLEMENTING THE USE OF

PSYCHEDELIC MEDICINES

MICHAEL J. WINKELMAN AND THOMAS B. ROBERTS

The authors of our chapters have tempered their encouraging results from

preliminary studies with reminders that psychedelic medicine has not yet

met the criteria of establishing medical safety and efﬁcacy with DBCS

(double-blind clinical studies) and the full phases of evaluation. To what extent

have psychedelic medicines passed the standards of clinical medicine or bio-

medical science? To what extent are these standards necessary and appropriate?

What uses of psychedelic medicines are justiﬁed in terms of the currently avail-

able evidence? And how might one avail themselves of these resources? These

questions are addressed in this chapter.

SCIENTIFIC EVALUATION OF PSYCHEDELIC MEDICINES

Where does the ﬁeld of psychedelic medicine stand with respect to

scientiﬁc and clinical evaluation? In order to assess this question of where

the ﬁeld of psychedelic medicine stands as an established set of treatment

tools with potential for the future, we employ the standard model of

different phases of evaluation, brieﬂy outlined by Frecska (this volume).

This involves:

Phase I studies which are primarily intended to evaluate safety (toxicity),

side effects, and safe dosage range, normally using small groups of healthy

subjects;

Phase II trials which use small groups of strictly selected patients to further

evaluate safety and to determine effectiveness and ideal doses for targeted

illnesses;

Phase III trials which use randomized clinical trials with large groups of

patients, who may have diverse comorbid conditions, to conﬁrm effectiveness,

monitor adverse drug effects and interactions, and compare the effects of the

new substances with commonly used treatments; and

Phase IV trials take treatments that have been shown as effective for a condi-

tion and use additional controlled trials to determine additional information

regarding side effects, safety, long term risks, and beneﬁts, and to perform com-

parisons with other procedures for the same condition.

Because of prohibition over the last 35 years, there have been difﬁculties

in achieving these phases of evaluation for the psychedelic medicines. Conse-

quently, our approach to assessing the evaluation of these medicines has to be

broader, and at times retrospective (in contrast to the prospective design of the

premarketing trials of the legal drugs) speciﬁcally:

Phase I studies relying on patient populations that have the possibility of

showing risks (adverse reactions) where none would exist in normal populations;

and Phase II studies that evaluate outcomes in patient populations, but not always

with the beneﬁt of the double-blind studies. This leaves open the possibility of

placebo effects, but for reasons discussed below, this may be viewed as an

acceptable part of a complementary treatment that relies on set and setting effects

as basic to psychedelic therapeutic processes. We characterize Phase II evidence

as “limited” when lacking certain features such as the beneﬁt of double-blind

controls or having been carried out with nonstandard patient populations.

Table 15.1 summarizes the data that has been presented by the authors of

the chapters here in this volume and Volume II. We suggest that this indicates a

generally well-established safety in studies to be considered here as Phase I.

To the extent that there are Phase II trials, many reﬂect the practices of the

1960s and consequently have lacked the standards of DBCS expected in today’s

more rigorous methodological climate.

Nonetheless, these less than ideal earlier studies, combined with a variety

of case studies and user reports and epidemiological studies, substantiate that

the broad range of psychedelic medicines are safe and apparently effective

adjuncts for a range of conditions, particularly the addictions (also see Volume

II). However, because of the lack of open research possibilities, we do not have

the full range of studies normally done to evaluate toxicity, nor effective trials

for Phase II and beyond for most of these substances.

While the double-blind clinical trials are limited, other forms of evidence can

be used. As Frecska (this volume) indicates, even when we include the statistics

on abuse as opposed to responsible use, there is evidence of little physical harm

272 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

from psychedelic medicines (Strassman 1984, 1994; Nichols 2004). Other

epidemiological approaches such as the use of cross-sectional (e.g., comparing

uses and nonusers) as well as retrospective (i.e., life history studies of users)

and longitudinal data can help reveal risks—or lack thereof. Such study methods

can be applied to cohorts of psychedelic medicine users and when compared to

appropriate matched control groups or population norms, can provide a basis

for asserting scientiﬁc evidence of safety.

As McKenna points out (this volume) with respect to ayahuasca, while

we lack controlled clinical trials, evaluations based on clinical judgments

of experienced practitioners point out that there is substantial evidence that the

psychedelic medicines are effective in the treatment of a range of conditions.

As Alper and Lotsof (Volume II) point out in their assessment of ibogaine, we

can begin to employ more complex, albeit less traditional, forms of validation

through a “triangulation” that combined data derived from animal research, the

numerous medical case studies and personal accounts of those who have received

these substances as treatments, and limited published case series. This would

constitute what we discuss here as “limited” evidence. Other criteria of the

effectiveness of medicines would include clinical judgment based on extensive

experiences (e.g., Grof 1979; also see Volume II chapters by Grof, Merkur,

House, and Walsh and Grob; similar cross-cultural uses and alleged effects (inde-

pendent invention/discovery); patient satisfaction and enhanced ability to engage

activities of daily living and lifestyle; and pharmacological studies indicating

biological mechanisms of action of active ingredients.

Ketamine: An exception to these generally cautious assessments of the

evaluation of these psychedelic medicines is ketamine (see Krupitsky and Kolp,

Volume II), which has received FDA (Food and Drug Administration) approval

for other uses and has been widely employed for the treatment of addictions in

Russia. These applications of ketamine were primarily as a research activity

and were NOT ofﬁcially registered with the Russian Ministry of Health for

approval as adjunct in the therapeutic treatment of addictions. Nonetheless based

on his assessment of the rules of the FDA, Kolp (pers. comm.) characterizes the

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 273

Table 15.1 Phases of Evaluation of Psychedelic Medicines

Psychedelic Phase 1 Phase II Phase III Phase IV

LSD Yes Limited

MDMA

Yes Currently

DMT

Yes No

Ayahuasca

Yes Limited

Psilocybin

Yes Yes

Mescaline/peyote

Limited Limited De Facto

Ketamine

Yes Yes Yes Current

Ibogaine

Yes Yes

Marijuana

Yes Yes

research of Krupitzky and his colleagues as constituting the completion of Phase

I, Phase II, and Phase III clinical trials in the ketamine psychedelic psychothera-

peutic treatment of alcoholism and opioid dependence. Currently, their research

constitutes the beginning of Phase IV in the United States as Kolp and colleagues

are initiating multicenter, randomized, double-blind studies of the ketamine

psychedelic psychotherapy. Krupitzky and colleagues are similarly at this phase,

currently treating in excess of 1,000 patients with ketamine psychedelic psycho-

therapy (Kolp, pers. comm.; see Krupitsky and Kolp, Volume II). Ketamine

constitutes a special case among the psychedelic medicines since it was already

an FDA-approved drug for more then 35 years ago. The FDA does not requires

the same registration procedures for a new (”off-label”) treatment as it does

for a new drug. Since its initial approval, research has been conducted on

ketamine off-label uses in the treatment of a variety of conditions including

chronic pain disorder, intractable seizure, strokes and heart attacks (Kolp,

pers. comm.).

Are Double-Blind Studies Appropriate Criteria for

Psychedelic Medicines?

The authors of our chapters have tempered their encouraging results from

preliminary studies with reminders that psychedelic medicine has not yet met

the criteria of establishing medical safety and efﬁcacy with DBCS. This “gold

standard” of biomedicine might seem to be the appropriate response from a pro-

fession (and society) that prides itself on the use of science to make decisions

regarding health resources. But is this in fact what happens? Does biomedicine

itself rely on the gold standard of DBCS to determine what treatments we can

receive? Or is the “gold standard” a kind of “double standard,” an ethnocentric

judgment applied more to others’ medicines rather than one’s own?

A variety of studies realized by agencies of the U.S. government have found

that only about 20–30% of commonly used biomedical procedures had actually

been tested with double-blind clinical procedures (see Cassiday 1996; McKee

1988 for references and discussion). Most of biomedicine’s common daily prac-

tices are not substantiated by the strictest criteria of medical science. No DBCS

are carried out on the use of multiple medications simultaneously, a common

aspect of biomedicine that causes drug interaction effects that constitute a major

cause of death in the United States.

The reasons why biomedicine does not rely strictly on DBCS are legion—the

difﬁculties with control conditions and blinds (e.g., what is involved in a double-

blind procedure for cardiac bypass surgery?); the ethical problems produced by

withholding a potentially effective treatment from someone who needs it in the

interest of a scientiﬁc study; and the funding sources and research priorities of

drug companies.

Biomedicine and the other ethnomedical traditions of the world rely on many

forms of evidence to establish some degree of certainty about the efﬁcacy of their

274 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

procedures. What should be the standards held for the use of psychedelic medi-

cines? This depends on the speciﬁc medicines, patients, and conditions.

But in spite of limited scientiﬁc studies of psychedelic medicines, most have

passed Phase I evaluations as generally safe, providing evidence that supports the

widespread application of psychedelic medicines, reclassiﬁed as Schedule II.

The range of conditions for which psychedelic medicines have been used are

limited, but given the wide range of uses found cross-culturally (e.g., see Schultes

and Winkelman 1996; Schultes and Hofmann 1979; Winkelman, Volume II) , they

ought to be evaluated for a wide range of supervised uses for many different con-

ditions including physical diseases and psychosocial and cultural-bound illnesses.

The DBCS must be understood in the context of the effort to separate the

placebo effect from the pharmacological action. These placebo effects are part

of the well-recognized powerful set and setting effects that determine the major

outcomes from use of psychedelic medicines. One of the challenges of psyche-

delic studies is the notorious difﬁculty in maintaining a double blind in it, as the

powerful effects become quickly apparent to patients and clinicians. Further-

more, the scientiﬁc necessity for control of the placebo effect is at odds with

the intent of many applications of psychedelic therapies, where the medicines

are used to amplify the set and setting effects through intention and focus of

attention and interactions with others. The placebo effects of set and setting are

so powerful in the case of psychedelic medicines as to have produced three major

paradigms of the psychedelics’ effects: psychomimetic, psycholytic and psyche-

delic (high dose) (Passie, this volume; Yensen 1985, 1996; Bravo and Grob

1989; Grob and Bravo 1995)

The effects of psychedelic medicines are to a great degree dependent on the

social dynamics and interpersonal relations of the sessions. This makes them

ampliﬁers of other dynamics and enhancers of other processes. This illustrates

that an important part of the mechanism of psychedelic medicines is the

placebo-psychological effect in a very broad way. Psychedelic medicines seek

to enhance placebo effects, and based on numerous self-reports they do. Control

procedures designed to reduce placebo effects also counter the basic mechanisms

affected by psychedelic medicines. If a basic premise of psychedelic medicine is

to enhance set and setting effects, placebo effects need to be included with the

treatment effect, not separated from it.

This notion of including the placebo may seem alien to medical researches

steeped in the traditions of the DBCS. But such approaches are becoming a stan-

dard in the context of integrative medicine, where the traditional biomedical

treatments are being integrated/combined with the so called alternative medicines

in a complementary fashion. The assessment methods in these approaches com-

pare patients receiving the standard biomedical treatment alone with patients

who receive standard biomedical treatment plus the “alternative/complementary”

treatment. Such additive models are often advocated by supporters of psychedelic

medicines, who see them as adjunctive to aspects of standard psychotherapeutic

care.

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 275

A closing note on the appropriateness of double-blind studies for evaluation

of psychedelic medicines should also consider the notorious difﬁculty in achiev-

ing this for medications that have such powerful effects. The ability of both

patients and clinicians to break the blind in psychedelic studies is well known.

The powerful effects of these substances make it difﬁcult to come up with an

appropriate control that evokes similar powerful experiences without compro-

mising the uniqueness of the psychedelic medicine (but see Grifﬁths et al.

Volume II). Consequently, the integrative open-label model may ultimately be

the best model for evaluations of psychedelic medicines, assessing how their

adjunctive use enhances the outcomes ordinarily achieved with standard

biomedical practices. And if this includes in part a placebo effect, we should em-

brace this as a positive outcome to be enhanced with the psychedelic medicines.

USE OF ANALYTIC DESIGNS FROM EPIDEMIOLOGY FOR PSYCHEDELIC

MEDICINE RESEARCH

The methods that epidemiologists use to identify risk factors associated with

speciﬁc diseases can be used to assess risks for psychedelic medicine use (see

Frecska, this volume) as well as the possible effectiveness of their use as treat-

ments for speciﬁc diseases. Epidemiological methods such as case control and

cohort studies (see Kelsey et al. 1996) can be used to examine at outcomes of psy-

chedelic medicine treatments. For instance, in the case of Sewell and Halpern’s

research (this volume) on the effectiveness of psychedelic medicines in the treat-

ment of cluster headaches, effectiveness can be assessed using methods such as

case control studies. This involves comparisons of those psychedelic medicine

“self-medicators” with a matched group that relied strictly on conventional medi-

cine. Case control studies draw inferences by making comparisons of a target

group (e.g., cluster headache patients who have experienced prolonged remission

from psychedelic medicines) with a matched control group of cluster headache

patients who have not them. Similarly, case control studies can make inferences

about the level of effectiveness of ibogaine treatment of heroin addictions

by making comparisons of the period of sobriety of heroin users who have taken

ibogaine with a control group of heroin addicts in recovery who have not used

ibogaine.

The relative ease of quick comparisons with case control studies can make

them useful for initial screening of the effectiveness of psychedelic medicines in

the treatment of new and intractable diseases or infrequent diseases. While there

are disadvantages to case control methods because of lack of accurate information

on risk factors and confounding variables, and recall bias, if the time sequence for

disease and exposure to psychedelic medicines can be established, there is a better

basis to infer cause and effect relationships. Cross sectional (prevalence) studies

normally assess data from a relatively short period of time. These studies normally

assess exposure and disease at the same time (e.g., hallucinogen use and cluster

headache symptoms), and then assess the prevalence of the cluster headache

276 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

condition in the different groups (psychedelic medicine users vs. nonusers).

In epidemiology, it is routine to use cross-sectional methods to assess existing

cases of disease and compares the rates for groups with and without exposure to

speciﬁc factors. Cross-sectional studies are particularly suited for studying dis-

eases that have a slow onset and long duration and are generally not identiﬁed

and cared for until they have reached advanced stages. This makes it possible

to see, for instance, if hallucinogen use may be preventive in some disease.

Retrospective (or historical) cohort studies can use medical history interviews to

determine the possible relationship of prior disease of psychedelic medicines to

the manifestations of conditions.

SUMMARY OF PSYCHEDELIC MEDICINE TREATMENT POTENTIALS

Halpern (Volume II) makes the point that considering the limited efﬁcacy of

current treatments for drug addiction, a problem that is evidenced in the high

rates of chronic relapse for these conditions, the use of psychedelic substances

for treatment of drug dependence is an ethical responsibility of the medical ﬁeld.

Given the much greater safer safety proﬁle of the psychedelics compared to

major addictive drugs (see Frecska, this volume), even repeated use of psyche-

delic medicines as treatments is more ethical than professional maintenance/

treatment programs employing drugs of high abuse or substitutes (e.g., metha-

done treatment or supervised application of heroin

) because of their abuse and

overdose potential.

Unfortunately, this option of safer and likely more effective treatment is

generally precluded by the control exercised by administrative law. This makes

it a moral responsibility of politicians to reverse this three and a half decade

prohibition on the use of these valuable medicinal substances.

As Frecska summarizes in his chapter here, we have begun to see the use

in well-controlled Phase II trials of several psychedelics such as ibogaine, mari-

juana, MDMA (3,4 methylenedioxymethamphetamine), and psilocybin.

But because of the great cost of a Phase III studies, there is little hope that we will

see these proceed without some changes in the government funding or industry

approaches that will make these substantial investments. Goldsmith (Volume II)

points to the need for changing the policies of bureaucracies, particularly at the

level of the U.S. Department of Health and Human Services, where the bureauc-

racy resists drug policy and research changes even where permitted by law. This

requires a public relations approach to changing public perceptions, which have

as of yet been a failure for those who favor drug policy reform. Goldsmith out-

lines processes of moving from awareness of issues to a broad enough public

interest to support changes in administrative policies that can lead to ultimately

achieve approval of these medicines as legitimate and mainstream approaches.

He points to a strategy of targeting people who are organizational levers and

administrative decision makers who are key to the introduction to new programs

and policy directions.

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 277

This will require strategic alignments with other interests, and Goldsmith

points out that treatment of central social problems such as addictions is a good

point at which to focus initial energies. Part I of Volume II attests to the wide

range of successful applications of psychedelic medicines to addictions. But to

change the political climate in the United States greater development of educa-

tion and advocacy groups will be necessary. These are the functions of many

organizations, including Drug Policy Foundation, DPA (Drug Policy Alliance),

MAPS (Multidisciplinary Association for Psychedelic Studies), and the CCLE

(Center for Cognitive Liberty and Ethics).

In the following sections we address four major interrelated approaches to

enhancing responsible access to psychedelic medicines through:

• Utilizing currently available psychotherapeutic and religious resources;

• Altering social attitudes through education and the media;

• Changing administrative policies through public policy, judicial, and

legislative approaches; and

• Inventing new approaches through a business or corporate model.

SELF-ADMINISTERED THERAPY

In Volume II, a variety of our authors (e.g., Merkur, Goldsmith, and House)

illustrate that a wide range of clinical knowledge has been developed regarding

the safe and effective use of psychedelic medicines. It should be noted that thera-

peutic recommendations for the use of psychedelic medicine includes the pres-

ence of qualiﬁed therapists. While there are uses of psychedelic medicines that

focus on individual self-administration (see Winkelman, Volume II), even those

are generally under the supervision of experienced healers. How does one get

qualiﬁed supervision in the current legal context?

Foreign Sources

The general lack of legal access to psychedelic medicine in the United States

suggests foreign treatment sources as a primary means of access. Foreign oppor-

tunities for loosely structured self-directed psychedelic therapy are found within

the mestizo and new age ayahuasca and San Pedro traditions of Peru. More

formal treatment protocols are available for the treatment of various addiction

problems, as discussed in the chapters by Mabit, Krupitsky and Kolp, and Alper

and Lotsof in Volume II.

The loosely self-administered therapeutic applications of ayahuasca mani-

fested in the international “drug tourism” (Dobkin de Rios 1994) provide

many North Americans and Europeans the therapeutic potentials of ayahuasca.

Ayahuasca ceremonies are available in much of South America, particularly the

Amazonian countries. Winkelman (2005) discovered that these people are in

278 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

search of the kinds of powerful personal and spiritual healing provoked by psy-

chedelic medicines. Contrary to the search for hedonistic highs implied by the

characterization as “drug tourists,” their principal motivations are characterized

by seeking spiritual relations and personal spiritual development; various forms

of emotional healing, particularly unresolved traumas; and the development of

personal self-awareness, including some sense of direct contact with a sacred

nature, God, spirits, and plant and natural energies produced by the ayahuasca.

Their motivations for their journeys andtheperceivedbeneﬁts that they report

both point to transpersonal concerns. The principal perceived beneﬁts involve

increased self-awareness, personal insights, access to deeper levels of the self that

enhance personal development, and expressions of the higher self which provided

personal direction in life (Winkelman 2005).

Wasiwaska, a Research Centre for the Study of Psychointegrator Plants,

Visionary Arts, and Consciousness established by Luis Eduardo Luna, exempli-

ﬁes a multifacted organization focused on the provision of private group therapy

with psychedelic medicines. Wasiwaska (the House of the Vine) is a legal Brazil-

ian nonproﬁt organization located in Floriano´polis, Santa Catarina, in southern

Brazil. This institute also promotes a variety of research projects on ayahuasca.

Domestic Adaptations to Prohibition

Eventually, there may also be several other approaches available to those

remaining in controlled areas through various forms of self-medication as

an adaptation of shamanism. These self-medication approaches may be both

solitary or interpersonal “recreational consumption,” or could potentially occur

in professional settings that are integrated into a semi-structured group thera-

peutic setting with ritual activities and processing. Psychotherapists might be

protected in an occasional practice where clients self-administer psychedelics

in a group retreat setting (see relevant discussion in Boire, this volume). Thera-

pists could probably ﬁnd protection by disclaimers and the provision of other

natural altered state of consciousness induction practices as part of spiritual

healing practices (e.g., see Winkelman’s chapter on shamanic guidelines

in Volume II). Therapist could obtain greater protection from persecution by

providing “psychedelic retreats” managed by therapists and in which each

client brought their own preselected particular psychedelic medicine.

Some other psychedelic treatments may not require the group dynamics to

the same degrees, such as with the cluster headaches. As Boire discusses, such

people who ﬁnd themselves driven to self-medicate with psychedelics might be

legally protected through documenting their medical needs and frustration with

conventional medicines.

It is imperative that we apply psychedelic medicines to the treatment of some

of the most ravaging social diseases of our times, the addictions to alcohol,

tobacco, and opiates and their synthetic derivatives. The generally acknowledge

success rate in the addictions treatment industry does not appear to be much

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 279

different from the spontaneous remission rate. And while Alcoholic Anonymous

and its derivative organizations do provide some degree of treatment success, it is

obviously not a successful venue for most addicts.

The range of psychedelic addiction treatments is truly impressive, as we

will see in the chapters of Part II, Volume II. Peyote, ibogaine, ayahuasca, LSD

(lysergic acid diethylamide), and ketamine are among the psychedelic medicines

for which we have substantial evidence of their effectiveness in addictions

medicine.

Religious Therapies

The existing legal frameworks discussed by Fenney (this volume), and

Groisman and de Rios’ (this volume) discussion of the cultural contexts of the

Brazilian Ayahuasca religions and the U.S. Supreme Court justices decisions,

establish some broad parameters within which religious formation, conversion,

and evangelism might extend the therapeutic applications of psychedelics as sac-

raments and entheogens. The ability to establish new U.S.-based local churches

of the Brazilian Ayahuasca churches may be protected in the current judicial

climate. Brazilian Ayahuasca religions coming to the United States are a likely

possibility. In fact, they are here now. Existing American religious groups

(e.g., Unitarian Universalists) could conceivably engage in ecumenical outreach

to ayahuasca churches, inviting them to the United States to share their

sacraments and expand religious/pastoral counseling through using psychedelic

medicines as entheogens.

The broader range of spiritual applications are indicated by authors in

Volume II, particularly the chapters by Grof, Walsh, and Grob, Marsden and

Lukoff, Winkelman, and who point to the transpersonal uses of these medicines.

The potential applications of these substances as entheogens are among the most

widely established in human history, although their place in modern medicine

has yet to be determined. Yet the work of Grifﬁth et al.’s (Volume II) illustrates

that these spiritual applications are reliably induced by psychedelic medicines,

pointing to a relatively unexplored aspects of human well-being that are

addressed by psychedelic medicines.

EDUCATION AND IMPROVING PUBLIC KNOWLEDGE

Education about the actual effects and potentials of psychedelic medicines

and other drugs is a crucial aspect of increasing the use of these resources, backed

by the knowledge of the parameters of their safe use and efﬁcacious effects.

A variety of policy organizations (see next section) have attempted to change

the opportunities regarding drugs through an education approach that focuses

on affecting public health policy. Their focus is to educate society, legislators,

and administrators regarding regulation of drugs based in science, compassion,

280 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

and activities that enhance health and protect human rights. Education is a central

tool in addressing the misinformation, fears, and prejudices that contribute to the

legal and administrative attitudes that waste resources in punitive activities and

prohibition efforts that produce more problems than they solve. Many problems

of addiction are caused by the drug war and oppressive judicial and administra-

tive measures rather than the drugs. Through education we can best hope to

advance drug policies that reduce harms of drug misuse as well as drug

prohibition. The kinds of evidence our authors provide in these two volumes are

a contribution to similar efforts. Two other educational venues merit special

notice—schools and the media.

Schools

When things in my (Roberts) honors seminar “Foundations of Psychedelic

Studies” start to drag a bit, I have found a topic that always enlivens the discus-

sion—the DARE drug education program. Spiced by snickers, guffaws, and roll-

ing eyes, the discussion heats up, and almost everyone in my class has a “horror

story” about this futile program. Why is drug education in failing health, and

how can it be revived? Truth is a powerful serum, but drug education programs

are about “Keeping kids off drugs” not about telling the truth, the whole truth,

and nothing but the truth.

Unfortunately, the biased and slanted information that my students report

represents the general state of drug education and public knowledge, both formal

education in schools and informal education in the news media. We hope these

two volumes will be a segment of the whole truth. And, of course, we are present-

ing up-to-date ideas on some medical aspects of psychedelic drugs, while a full

picture would be vast and include not only psychedelic drugs but also other

psychoactive drugs, and it would stretch beyond medicine to the arts, sciences,

religion, and elsewhere.

One reason our culture has such a difﬁcult time thinking clearly about drugs is

that our system of ideas is adapting only slowly to recognize that there are beneﬁts

of using other mindbody states (states of consciousness) in addition to our

ordinary awake state (Roberts 2006). When the psychedelic 60s erupted decades

ago, an interest in mindbody practices such as meditation, yoga, or breathing

exercises were largely misinterpreted and mistrusted. Now churches teach media-

tion, park districts and schools offer yoga classes, and health professionals teach

relaxation exercises; over the decades, our culture is becoming educated about

the beneﬁts of mindbody psychotechnologies and coming gradually to accept

them. Also, during this time the number of prescribable, psychoactive medicines

has—ahem—mushroomed. Culturally, we still have much to learn from some

premodern societies about other mindbody states, ways to access them, and how

to use them (Winkelman, this volume and Volume II).

From a scientiﬁc perspective, presenting partial information as if it were the

whole story is little different from lying. Everything one says may be true, but if a

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 281

biased selection of the information misrepresents the whole evidence, this is

likely to lead to a misleading conclusion. This is the way lawyers work, not scien-

tists: lawyers start with the conclusion and marshal evidence to support it. Along

the way, they disregard conﬂicting information. (It may be no odd occurrence

that most politicians, who set drug policy and fund drug education, are lawyers.)

Scientists, on the other hand, will include all the information and ask: “What con-

clusions does this evidence require us to make?” Most drug education programs

work in the lawyerly way: they start with the conclusion that all drug use is

bad, then they collect the information that supports their prejudged conclusion.

This has a tragic downside: judging from my sample of college juniors, when

we present biased information about drugs, students come to recognize this and

throw out the realistic cautions because of the exaggerated fears. If anything they

are taught is wrong or misleading, the baby of realistic warnings gets thrown out

with the dirty waters of lies and exaggerations.

News Media as Educators

On a wider social scale, our educators are the news media, and with some

notable exceptions, they are little better than DARE.

A DOZEN HANDY GUIDELINES FOR REPORTING ON DRUG RESEARCH

In 1997, a group of leading scientists, law enforcement specialists, and health

policy experts proposed a 14-point Principles for Practical Drug Policies (Feder-

ation of American Scientists). Among the 14 policies they recommend as “a

middle way” was a drug policy based on scientiﬁc evidence, civility toward those

with different solutions, and honesty about facts, proposals, and motives. How

might a responsible news media write fact-based news stories and educate people

on psychedelics and other psychoactive drugs? The following questions will help

reporters clarify drug issues, and readers judge the content of the stories they read.

When they receive information about drug studies or talk to ofﬁcials, they

can ask the following questions.

Was the drug used actually the same as the drug reported on? During the

early press reports of MDMA (Ecstasy, X, and the rave drug), the press reported

results of MDA (methylenedioxyamphetamine) research as MDMA research.

Even a very slight change in a molecule can greatly change its biological and

psychological effects.

Was the route of administration the usual route? The effects of a drug vary

greatly according to the four S’s — whether it is smoked, swallowed, snorted,

or shot. For example, when a drug is swallowed, a great many biological events

take place in the stomach and liver before the drug is generally circulated in the

blood stream. Injections, which are usually used in animals, bypass this process.

When a drug is smoked, some chemical structures are broken, and new chemicals

can be formed.

282 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

Was the research in vitro (test tube) or in vivo (in living organisms)? Sub-

stances induce a cascade of biological events in living organisms, but this number

is drastically diminished in a test tube. Some side effects (both desirable and

undesirable) are missed in the test tube, and some effects that appear in the test

tube would not occur in a living body, or would occur at a much diminished

degree.

Was the dosage typical of common usage? It makes little sense to claim a

drug has an affect if the dosage was extremely high or low. When a researcher

reports that the dosage was, say, “x milligrams per kilogram of body weight,”

reporters and readers or TV viewers should ask, “What is the typical concentra-

tion in a typical user?” Researchers should compare the experimental dose with

the typical use. It is helpful to think of street use in terms of a normal curve,

which range from very low to very high doses, but with the majority in the

middle. Where do the problems derive? From “normal” doses or the high

extremes?

Was the research done on people or other animals? Reports of behavioral

change by psychoactive drugs in animals are minimally generalizable to humans.

Biological activity such as attachment at receptor sites is more applicable. The

lack of generalizability is especially true for drugs which are taken primarily

for their effect on thinking and emotions. What does it mean to say that a drug

effects cognitive processes of a rat or gives a sense of well-being to a monkey?

Was an alleged drug actually the drug taken? This is especially a problem

with “street drugs.” A dealer who is out of a certain drug may substitute another,

and the purchaser may attribute his/her experience to the wrong drug. This is also

a problem with dosage and contamination. Information based on street drugs and

research based on pure laboratory samples may or may not apply to each other.

How typical is an expert’s report of a drug’s effects on humans? Doctors,

police ofﬁcers, and mental health professionals are likely to see people who have

had bad effects of drugs. Although their sample is skewed toward reporting ill

effects, it probably is useful in answering the question, “What are the possible

dangers of this drug?” Their experience is not accurate in answering, “What is

atypical effect of this drug?” Asking most drug specialists about drugs is like ask-

ing a divorce lawyer about marriage.

Does “drug-related” mean “drug money related”? Most “drug related

violence” does not come from using drugs but comes from ﬁghting over

the money associated with drugs—to obtain the money to buy drugs, ﬁghting

over the proﬁts, intergang competition, debts, etc. Drug trafﬁcking is a lucrative,

tax-free business that is engaged in for proﬁt.

What are the “set” and “setting?” In human subjects, major effects of

psychoactive drugs result from the person’s “set” (expectations, mood, and frame

of mind) and “setting” (location). In psychoactive drugs, set and setting are

primary inﬂuences. This applies less to drugs which are taken for somatic, bodily

purposes; thus, when medical doctors think about the effect of a psychoactive

drug, they may not recognize the primacy of its set and setting.

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 283

Why do people do this drug? Whenever a large number of people do some-

thing, it is worth assuming there are many reasons, and most people probably

have a mixture of reasons. A way to test the expertise of an alleged “expert” is

to probe to see if he or she recognizes multiple reasons why people like drugs.

It is worth asking, “What beneﬁts do people who use this drug think (rightly

or wrongly) they are obtaining?” The more complex the answer, the greater the

likelihood you have a well-informed “expert.”

Talk to people who have actually taken the drug. The news stories I read

seem to rely on third parties telling why they think people do the drug being

reported on. “Peer pressure” and “to escape reality” are probably true some of

the time, but if we want to write policies to affect people’s behaviors, can we

do so without knowing why they do those behaviors? Most people voluntarily

take drugs because—rightly or wrongly—they think they beneﬁt from doing so.

What are these alleged beneﬁts?

Why are you telling me this? Reporters and editors are taught to be skeptical,

always to have the questions “Why are you telling me this?” and “What will you

gain if I report this?” in the back of their minds. But for some reason, they naively

switch off these questions for drug stories. They know that other governmental

press releases, news conferences, and interviews are provided in order to get

an agency’s message across, and an implicit or explicit background theme for

many such news events is we need more funding. Since the funding of drug war

agencies depends on their ability to scare people about drugs, the bigger the

scare, the greater the funding.

Unfortunately, much drug reporting is naive, divisive, sensationalistic,

and simplistic. Reporters can educate the public and increase the accuracy

of their stories by exercising the common skills of reportorial skepticism, and

readers can understand drug news stories better by asking questions based on

common sense.

PUBLIC HEALTH POLICY, JUDICIAL, AND LEGISLATIVE

APPROACHES

There is a surprising large number of organizations supporting reform in

drug policies and rational approaches based on both rational evidence and human

caring.

Drug Policy Alliance

The DPA (see www.drugpolicy.org) points out that it is the state legislatures

which have traditionally been at the forefront of policy change on drug laws.

Local context provides “laboratories” for experimenting with new ideas and

potential solutions. This isexempliﬁedindrugpolicyreformonissuessuchas

drug sentencing, medical marijuana use, overdose prevention and treatment

284 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

programs, and the expansion of drug treatment services. The “Drug Policy

Reform: the State of the States, 1996-2002” (DPA, www.drugpolicy.org) summa-

rizes many of these developments promoted by local voters and state govern-

ments who have enacted more than 150 signiﬁcant drug policy reforms

during the last decade. While the DPA’s focus on education has focused on mari-

juana and other commonly used illicit drugs, it has provided a context within

which to discuss alternatives to current drug policies and treatment alternatives

to incarceration.

For example, the DPA organized voters in Oakland, CA, to support Medical

Marijuana use through a ballot measure that established a framework for decrimi-

nalizing marijuana and making it the local police’s lowest enforcement priority,

instead focusing their resources to address violent crime. Although local ordinan-

ces have allowed for local use of some substances such as marijuana, there

has been a constant battle with the federal authorities who feel that they are not

limited by state initiatives.

A signiﬁcant feature of the policy advocacy has been a focus on harm reduc-

tion strategies that attempt to reduce problems, particularly those associated with

enforcement. The ideas of reducing harms can be expanded to appreciating

potential beneﬁts where substances have proven medicinal uses, maximizing

potential beneﬁts of psychedelic medicines through their judicious use. These

possibilities for the broader use of psychedelic medicines have not yet been a

signiﬁcant focusing of the referendum process, the milder marijuana typically

being the focus of the referendum process. Nonetheless the role of the DPA

and similar activist organizations in supporting the development of legislative

and referendum work at the state levels leaves open the possibility of legislated

treatment programs in the same way that we have seen legislated needle

exchange and methadone programs.

A signiﬁcant feature of this multifaceted approach has been to include a con-

tinued and expanded resistant to the War on Drugs. The immense expenditure

focused on the arrest, prosecution and incarceration of tens of thousands of

persons each year for crimes associated with the possession and use of illegal

drugs has led to an erosion of many constitutional rights. The War on Drugs is

a war on public health that has been resisted by public health organizations

such as the American Public Health Association, as well as other professional

organizations such the American Society of Addiction Medicine, the National

Association of Alcoholism and Drug Abuse Counselors, and the American

College of Obstetricians and Gynecologists.

Center for Cognitive Liberty and Ethics

Combined education and legal approaches have been emphasized by

the CCLE (www.cognitiveliberty.org) as well. The CCLE is a network of

scholars that address issues in the intersection of law and policy issues as they

pertain to cognitive freedoms to use psychedelic medicines and other drugs.

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 285

Their educational and policy approach has addressed policies necessary to

preserve the ethics of the freedom of thought regarding these substances.

The clinical applications of psychedelic medicines clearly move the con-

cerns beyond the context of purely medical use and into the improvement and

enhancement of cognitive abilities. They emphasize the importance of protecting

personal freedoms involving the exploration of the capabilities of our own minds

as a direct right as long as it does not directly harm others. There are many forms

of resistance to the governments’ efforts to limit and criminally prohibit forms of

consciousness and cognitive enhancement. The CCLE has emphasized the

importance of social impact litigation as a process for broadly advancing the

potential to exercise our cognitive liberties, and has ﬁled legal briefs on the topic

of cognitive liberty in federal court. But central to their efforts is raising aware-

ness of the emerging issues of cognitive liberty through outreach and education

campaigns designed to provide people with the information necessary so that

they can empower themselves to participate meaningfully in public discourse

and affect relevant democratic processes.

Multidisciplinary Association for Psychedelic

Studies

The combined public education, research, and policy efforts necessary to

change the political climate limiting the use of psychedelic medicines are

exempliﬁed in MAPS (see www.maps.org). MAPS is a membership-based non-

proﬁt research and educational organization founded in response to increasing

governmental control exempliﬁed in the classiﬁcation of MDMA as a Schedule

1 drug by the DEA (Drug Enforcement Administration). MAPS exempliﬁes the

private sector organizations that take a multifaceted approach to changing the

political climate through education, organization of local political efforts,

lawsuits, and research funding. Its scope of activities range from a research

mission engaged in sponsoring scientiﬁc researchers to spearheading efforts to

obtain governmental approval for research projects, engaging in fund raising

activities, and conducting and reporting on psychedelic research to make neces-

sary information available to legislators, administrators, and the voting public.

MAPS programs exemplify the need to address these issues of personal con-

sciousness and cognitive freedom, embodied in the conﬂicts of the politically and

ideologically driven War on Drugs with personal and scientiﬁc freedoms. This

negation of science has led to gross social problems, embodied in economic, civil,

and social problems from drug enforcement rather than drug use. MAPS has

played a signiﬁcant role in pointing to the source of these conﬂictive societal

dynamics in the deep-seated cultural traditions, and the collective and individual

ambivalence about spiritual experiences. MAPS seeks to achieve a balance

between adequate control of powerful psychedelic medicines and the rights of

scientiﬁc researchers, clinicians, patients, and people with a nonmedical interest

in the applications of these in spiritual, recreational, and creative contexts.

286 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

Through the funding of research, MAPS contributes to the development of

beneﬁcial applications of psychedelic medicines in psychotherapeutic practices

and physiological research, as well as treatment of pain and addictions

and exploration of spirituality, creativity research, shamanic healing, psychic

abilities, and a range of research projects on brain physiology. It supports a range

of projects (e.g., see chapters in this volume, such as Abrams’). Because of

funding provided by organizations like MAPS, research teams are able to

operate in other countries where restrictions are less onerous (e.g., Canada,

Israel, Russia, and Switzerland).

The Federal government’s administrative apparatus has proven to be

a major impediment to research, imposing a range of administrative barriers

that preclude access to needed medicines or approvals for studies (e.g., see

Strassman 2001). MAPS has sponsored lawsuits against DEA for their refusal

to issue the required permits for growing facilities, access to drugs and approvals

for applications, a venue that will be increasingly necessary to ﬁght against

the arbitrary bureaucratic impediments to legitimate research and treatment

[also see Doblin’s (2001) doctoral dissertation “Regulation of the Medical

Use of Psychedelics and Marijuana”].

The need to act at the level of the election of sympathetic federal ofﬁcials—

including the president—is emphasized in the MAPS statement that “there

will probably be no privately-funded medical marijuana research effort ever

started until a more reasonable President is in ofﬁce.” Other venues of action

for overcoming administrative and judicial impediments could include a

campaign of pressure through letters of support from members of Congress to

inﬂuence the DEA Administrator to make favorable recommendations. In the

face of federal level opposition to research, the development of state-level

reforms becomes even more signiﬁcant.

But organizations such as MAPS depend on public support, which is

limited and insufﬁcient for the range of research projects currently awaiting

support. MAPS uses private donations and other forms of fund raising to

acquire resources to fund research for scientists to design studies, seek funding,

and obtain necessary institutional and governmental approval for studies

into the risks and beneﬁts of psychedelic medicines. A speciﬁc focus of

MAPS’ mission has been to sponsor scientiﬁc research necessary to seek

FDA-approval for the use of psychedelics and marijuana as prescription

medicines. This also requires a public education approach to provide

correct and honest information about the risks and beneﬁts of psychedelic

medicines.

MAPS educational mission is complemented in its operation as a nonproﬁt

pharmaceutical company with the priority of researching the potential of

MDMA (Ecstasy) and marijuana as FDA-approved prescription medicines.

The formidable expenses normally involved are illustrated in the MAPS estimate

of a $5 million cost for the ﬁve years of research necessary to meet FDA

criteria for the safety and efﬁcacy of a single psychedelic medicine for just

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 287

one clinical indication. These costs make the idea of a business model—a corpo-

rate approach—an almost necessary avenue for exploration and development in

the current political climate.

A CORPORATE SOLUTION

How might we use psychedelics most advantageously and at the same

time limit their risks? As these two volumes of this book and especially this chap-

ter and the concluding chapter of Volume II show, the diversity of psychedelics’

possible uses leads to a diversity of ways to embed them in existing institutions

and possibly new ones. In these concluding chapters, we regard only a few

of them.

When I (Roberts) ﬁrst considered a corporate answer to how to develop

psychedelics safely and efﬁciently, I thought about writing an essay proposing

such a company, but my thoughts kept leapfrogging from ordinary sentences

and paragraphs to imagining what a prospectus for such a company would look

like. How could these ideas make sense to Wall Street types? How might the City

act? Rather than write a straightforward narrative essay and hope that some day

the essay would inspire a startup company, my mind jumped immediately to a

prospectus-as-essay.

Like science ﬁction, this part of our concluding chapter is business ﬁction.

Sciﬁ ideas often presage actual events and inventions. Similarly, this attempt at

bizﬁ may foretell the future too. Here are selected ideas from that longer, ﬁctional

prospectus.

PRELIMINARY PROSPECTUS

Community Psychedelic Centers International, Inc.

Incorporated in the State of Delaware

An offering of 10,000,000 shares of common stock at $20 each

SUMMARY Community Psychedelic Centers International, Inc., (“CPC or

“the company”) anticipates offering 10,000,000 shares of common stock on or

about (date forthcoming). This will be the initial public offer for the company

and may represent special risks. The company expects to provide two types of

services: (1) psychedelic-assisted psychotherapy and (2) and psychedelic-

assisted professional development (See “The Company’s Business” below). With

the proceeds of this offering, the company expects to establish therapeutic centers

and professional development centers. The therapeutic centers will consist of

(1) free-standing, self-contained centers for referral patients and (2) on-grounds,

in-house centers located at existing major mental health hospitals and centers.

The Professional Development Centers will provide service for clients who wish

288 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

to enhance religious experience, creativity, personal growth, academic and

scholarly research, and similar non-therapeutic purposes.

The company believes it has already identiﬁed several potential drug candidates

as investigational new drugs, and furthermore, that while additional studies

may be required to ﬁrmly establish their safety and efﬁcacy, preliminary studies

support both their safety and efﬁcacy.

The company will receive approximately 85% of the proceeds of this offering.

The underwriters will receive approximately 1% for underwriting and miscella-

neous fees, and approximately 14% will go to the individuals who comprised

CPC Partners and are now the current stockholders.

Underwritten by

Hofmann & NiewKranium, Inc.

Member of the Zurich, New York, and Amsterdam Stock Exchanges

HANDPRIK & TWIST, inc.

Member of the Sausalito, La Honda, and Montauk Stock Exchanges

The Company

The CPC (Community Psychedelic Centers) Partnership was formed with

20 partners. This partnership organized CPC International, Inc. and incorporated

it in the state of Delaware. CPC has applied to the FDA to commence clinical tri-

als of several drugs which CPC believes offer advantages as adjuncts to psycho-

therapy. CPC also believes these drugs as used within the conﬁnes of the

proposed sessions are effective methods of increasing professional development

including, but not limited to, creativity and problem solving, providing insights

of value to academic and scientiﬁc researchers, enhancing primary religious

experience, stimulating artistic works, and exploring and developing the human

mind. No assurance can be given that the candidate drugs will prove effective,

and if they are, no assurance can be given that the FDA will approve their uses

as anticipated by CPC.

CPC believes that these drugs should not be prescribed to patients in such a

way that the patients can buy them and self-administer them, but that their proper

use requires the presence of fully trained professionals. Patients may not take

these substances home with them. An analogy might be anesthetics, which are

administered only by properly prepared professionals.

TRADING SYMBOL

CPC International has applied to the NASDAQ (National Association of

Securities Dealers Automated Quotation system) to trade CPC stock under the

symbol LSDD.

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 289

CHARITABLE ALLOTMENT

An unusual feature of this offering is the “charitable allotment.” Purchasers

of these shares at the underwriting are required to donate half their purchases to

a charity recognized as such by the U.S. Internal Revenue Service or by appropri-

ate state, local, or national laws in the jurisdictions where purchasers reside.

For example, if someone buys 200 shares, he or she must donate 100 shares to a

recognized charity. These shares are fully registered and identical to all other

units. CPC’s tax consultants believe that such gifts may qualify as a charitable

donation for Federal Income Tax purposes, but the Internal Revenue Service has

not made a determination on this issue.

CHARITABLE CHOICE—PSYCHEDELIC FOUNDATION

Investors may select any charity or charities of their choice, such as a church,

university, museum, community organization, or other legally recognized

eleemosynary institution. CPC partners has established Psychedelic Foundation,

Inc. to receive these and other donations if investor-donors so desire. Psychedelic

Foundations is entirely separate from CPC, and its charter allows it to fund a wide

variety of health-related, educational, religious, scientiﬁc, civic, and other pro

bono projects. This includes, but is not limited to, paying fees for treatment and

services for people who cannot afford to pay for CPC’s services. Although CPC

Partners hopes investors will contribute their charitable allotment so as to further

psychedelic research, either through Psychedelic Foundation or through organiza-

tions such as the MAPS, the Albert Hofmann Foundation, or the Heffter Research

Institute, the underwriters will not give preference because of the charity which is

to receive the donor shares.

Services

Unlike pharmaceutical companies, whose business is the manufacture and

sale of pharmaceuticals, CPC’s primary business will not consist of drug sales

but will consist of the service of providing professionally guided psychedelic

“sessions.” CPC may derive income from the manufacture and sale of its drugs,

but this is expected to be incidental to the company’s main business. The com-

pany’s primary service will include screening and preparation for the sessions,

conducting the session, and follow-up.

The company’s structure consists of two divisions, the Psychedelic Therapy

Division and the Psychedelic Professional Development Division. The company

calls prospective purchasers of the services of the Psychedelic Therapy Division

“patients” and calls prospective purchasers of the services of the Psychedelic

Professional Development Division “clients.”

Depending on regulatory and other matters, the two divisions and their

centers may be located in the same state or in different states and in the same

nation or in different nations. They may also be housed together or separately.

290 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

SESSIONS

Both therapeutic services and professional development services will consist

of four phases: (1) screening, (2) preparation, (3) the session, and (4) post-session

follow-up. Because these differ according to the nature of the patients and clients

and the nature of the desired outcomes, the details of the procedures are only

summarized here and are more fully described in Manual of Procedures for

Psychedelic Sessions, which is incorporated herein by reference.

Screening consists of physical and psychological examinations to determine

whether the applicant, clients, and patients are physically hardy enough to with-

stand possible stressful emotional and psychosomatic stress. Preparation consists

of determining the client’s/patient’s personal preferences of setting and explain-

ing to the client/patient the kinds of experiences he or she is likely to experience

during the session, the activities which may occur (such as listening to music),

and so forth. It will include establishing rapport with the guide or guides who will

attend the patient/client during the session day. A typical session will take a full

day. The client/patient will be accompanied throughout the session by at least

one professional.

After a session, which may last 12 hours or more, clients and patients may

stay overnight at the center or may be accompanied to their homes. In the case

of patients who are residents at mental health treatment facilities, they will be

returned to the custody of their institutions either the same day or they may stay

overnight and return the next day. During the follow up, the session and its effects

will be evaluated. In the case of patients, this activity will include consulting

and/or reporting to the patient’s doctor and/or therapist. In the case of clients,

the client, as well as the sessions guide, will typically evaluate the outcome.

Owing to the nature of psychedelic sessions, the follow-up evaluations may

include unanticipated results as well as the intended ones.

THERAPY DIVISION

Psychedelic Therapy Centers will provide services only to clients who are

referred by mental health professionals who are certiﬁed or licensed in the juris-

dictions where the centers are located. In the United States, these will vary from

state to state. Internationally, these will vary from country to country. Ofﬁcially

recognized competent authorities are likely to include, but not be limited to,

psychiatrists, clinical psychologists, and others similarly licensed or certiﬁed.

At the present, CPC believes its proposed therapeutic services have been

shown by preliminary studies to be safe and efﬁcacious for the following indica-

tions: alcoholism, drug addiction, post-traumatic stress disorder, lost memory

recovery, depression, autism, and selected neurotic and psychotic diagnoses

recognized in the Diagnostic and Statistical Manual - IV. Regulatory approval

will require additional studies to establish these claims.

As experience with these drugs and CPC’s method of running sessions

increases, CPC believes that other indications will emerge. Among these is the

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 291

possibility that intense, overwhelming self-transcendent experiences may boost

the immune system. CPC believes that to date existing studies suggest this may

be the case, but that such evidence is not strong, and that additional studies may

or may not conﬁrm these leads.

Psychedelic Therapy Center’s current plans call for some of its centers to

be located in-house or on the grounds of existing mental health facilities

such as state mental hospitals, private residential treatment centers, and similar

locations. Other centers will be located as free-standing centers. CPC envisions

free-standing centers located so as to serve the needs of several mental health

facilities and professionals in an area.

CPC believes that psychedelic sessions also have value in the training

of mental health professionals and will provide both preservice and in-service

education for these groups. CPC plans to apply to appropriate governmental

agencies and/or educational accrediting agencies for permission to offer Contin-

uing Education Units, “CEU’s.” In some cases, these CEU’s may be offered

in conjunction with educational institutions such as medical schools, nursing

schools, institutions of higher education, professional societies, and others. While

CPC believes enough referrals will occur to make the Psychedelic Therapy

Centers proﬁtable, no assurance can be given that this will be the case.

PROFESSIONAL DEVELOPMENT DIVISION

Psychedelic Professional Development Centers will provide services

for professional and vocational development in business, religion, education,

scholarship, science, law, mental health, the arts, and related ﬁelds. Instead of

being undertaken for the purpose of curing an existing mental health condition,

sessions will be undertaken to work in these ﬁelds. CPC believes this division’s

proposed services have been shown to be safe and efﬁcacious, but it makes

no assurance that regulatory agencies will interpret the existing studies this

way. A major barrier to regulatory approval is the assumption that psychoactive

substances have appropriate use only in medicine and psychotherapy. CPC

may have to undertake, or cause to be undertaken, additional studies to

provide evidence of the usefulness of psychedelic sessions for nonmedical

purposes.

Because the proposed activities of the PPDC are not medical or psychothera-

peutic, it is not clear which governmental agencies, if any, have jurisdiction over

these issues. This unresolved regulatory issue is especially acute for the religious,

artistic, and educational uses because these areas have traditionally been outside

U.S. government control. Pending the resolution of this issue, CPC may establish

its ﬁrst Professional Development Centers outside the United States.

Clients of the Professional Development Division must be certiﬁed as at

low risk of aversive consequences from their sessions, and like the patients of

the Psychedelic Therapy Centers, they will undergo screening, preparation, the

session itself, and post-session follow-up.

292 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

Some Psychedelic Professional Develop Centers may be associated within

one speciﬁc institution such as a major university, research facility, church,

or monastery; others may serve consortia of institutions; and others may be

associated with, or sponsored by, professional organizations.

DRUG DISCOVERY AND CANDIDATE DRUGS

While most pharmaceutical companies and drug discovery companies spend

many years and much effort identifying new drug candidates, CPC believes it has

already identiﬁed potentially successful investigational new drug candidates,

including LSD, DPT (dipropyltryptamine), DMT (dimethyltryptamine), MDA,

MDMA, psilocybin, ayahuasca, and mescaline. Other compounds may be added

from time to time.

DRUG TESTING AND APPROVAL

Because appropriate Federal agencies in the United States and in

selected foreign countries have already granted some of these drugs the status

of Investigational New Drugs, CPC believes its applications for approvals as

treatments will move expeditiously if additional scientiﬁc and medical studies

are successful.

Investment Questions

How likely is this busﬁ idea to presage such a company and an initial public

offering of its stock? Are there people who would invest in it? The chapters

in these two volumes indicate a wide variety of possible medical and psycho-

therapeutic applications, and the concluding chapter of Volume II describes

nonmedical applications from creative problems solving and scientiﬁc insights

to education and spiritual development. Many people already know of psyche-

delics’ positive uses, making them potential investors. Some potential investors

have experienced psychedelic drugs themselves and believe they have beneﬁted

from them; others know people who have experienced psychedelic drugs and

believe they have beneﬁted from them; still others are familiar with the scientiﬁc

and medical ﬁndings in pilot and preliminary studies.

PSYCHEDELICALLY INFORMED

Is there enough ﬁnancial interest to organize such a company and offer its

stock to the public? According to the 2002 National Survey on Drug Use and

Health, 24,500,000 Americans have ever used LSD. The 2002 National Survey

of Drug Use and Health estimates that 34,300,000 Americans have ever used

some form of hallucinogens, with that number climbing every year. Here are

another 10,000,000 people with some percentage wanting to invest in LSDD

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 293

stock. If even 1% of the LSD number was likely investors that would be 245,000

people; of course, the actual number may be larger or smaller.

To start conservatively and consider only retirement accounts in the United

States—IRA, 401(k), 403(b), and similar accounts—for only 1% of the former

LSD users and assumed investments of $5,000 per person:

245,000 ×$5,000 = $1,225,000,000

Presumably, some investors would want to invest more than $5,000 per

person.

LARGER RESERVOIRS OF MONEY

Individually controlled retirement funds are only a small slice of the overall

equity investment pie, and other sources of funds exist. Mutual funds, banks,

insurance companies, pension plans, and similar ﬁnancial ﬁduciaries are bigger

pools of funds. Could these numbers be doubled or more than doubled when we

consider foreign investors? There are some very wealthy individuals and venture

capitalists who realize the business potentials of psychedelics and know a good

speculation when they see one. It is widely rumored that among the Silicon

Valley multimillionaires and billionaires, there are many who use psychedelics

or have used them in the past.

DUE DILIGENCE

But would professional investors want to take the risk of investing their

clients’ funds in LSDD? Exercising ﬁduciary responsibility requires them to

carefully and thoroughly investigate possible investments for both their risks

and for possible rewards. To do this for CPC, these ﬁnancial intermediaries

(people who handle other peoples’ money) would have to acquaint themselves

with the research such as the chapters in these two volumes and similar sources.

While they probably wouldn’t read the psychedelic research on their own, exer-

cising “due diligence,” as it’s called, would inform them about psychedelics’

potentials. An ironic side-beneﬁt from a psychedelic stock offering is educating

large and powerful groups about psychedelics’ beneﬁts. This beneﬁt is not to be

underestimated.

Another byproduct beneﬁt of a psychedelic stock offering is that CPC would

need medical and scientiﬁc research done. Just as happens with pharmaceutical

and healthcare companies now, some of the funds raised would ﬂow to univer-

sities and medical research institutes. Additionally, owners of LSDD could

develop into a supporting constituency for supporting both CPC, speciﬁcally,

and psychedelic research, in general. The charities that received their pro bono

charitable allotments—churches, schools, universities, museums, hospitals, civic

organizations, and so forth—would share an interest in psychedelics, learning

294 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

about them and supporting further research. Again, the effect of this should not be

underestimated.

In a broader framework, the chapters in these two volumes are about much

more than curing speciﬁc illnesses; their implications go far beyond the ﬁeld

of medicine and healthcare. As this concluding chapter of this volume and

its companion concluding chapter of Volume II propose, used carefully,

psychedelics’ beneﬁts can extend to education, the arts, and religion (Roberts

2001, 2006) as well as medicine. As this section of the chapter shows, the

business community can beneﬁt from psychedelics and hasten these beneﬁts for

society.

CONCLUSIONS

The conclusions and recommendations we have considered here and the drug

policy groups we have listed are only some of the ways and means of strengthen-

ing drug policy and appropriate medicinal applications. The Internet web sites we

have given provide many links to other ways. We recommend you explore them

and the chapters of Volume II where many other aspects of the applications of

psychedelic medicines are explored.

NOTES

Thanks to our contributors for making these conclusions more apparent through

their research and the reports provided here. These assessments of the therapeutic poten-

tials need to be considered in light of the recommendations made in the previous chapters,

especially Passie, Frecska and Greer, and Tolbert.

1. Thanks to Ede Frecska for his assistance in constructing this section, and the

information provided by our contributors, especially Krupitsky and Kolp.

2. For Phase I, see Farber et al. (1998); Phase II for “limited” evidence, see

Grof (1975; 1979); Halpern, Volume II.

3. We characterize Phase II evidence as “limited” when lacking the beneﬁt of

double-blind controls but strongly suggested from less rigorous forms of validation such

as animal research, medical case studies, and personal accounts and case series.

4. MDMA has undergone several studies constituting Phase I trials, both in the

United States and Europe, with hundreds of participants evaluated in controlled studies.

For MDMA Phase I studies, see De la Torre et al. (2000); Grob et al. (1996); Liechti

et al. (2000); Vollenweider et al. (1999); Gamma et al. (2000); Gouzoulis-Mayfrank and

Daumann (2006); also see Mithoefer (2003); for current Phase II studies see Mithoefer,

this volume.

5. For Phase I studies of DMT, see Strassman (2001).

6. For Phase I studies of Ayahuasca, see Grob et al. (1996); Callaway et al. (1999);

for limited Phase II evidence, see McKenna, this volume, Mabit, Volume II.

7. For Phase I and II evaluations of psilocybin, see Moreno and Delgado, Grob, this

volume; Volume II.

GUIDELINES FOR IMPLEMENTING THE USE OF PSYCHEDELIC MEDICINES 295

8. For Phase II evaluations, we have case studies of Peyote Church members

(see Halpern 2004; Halpern et al. 2005 for reviews); for evidence of Phase III–approved

therapeutic use, we have the practice of the Indian Health Service, a branch of the

U.S. federal government, approving use of peyote for treatment of alcoholism among

Native Americans (see Calabrese, Volume II).

9. Ketamine is already classiﬁed as a Schedule III drug, with approved uses. Phase I,

Phase II, and Phase III clinical trials in the ketamine psychedelic psychotherapeutic treat-

ment of alcoholism and opioid dependence have been carried out, and currently there is

research that constitutes the beginning of Phase IV (see Kolp and Krupitsky, Volume II;

Krupitsky et al. 2002).

10. The FDA approved clinical trial of ibogaine which were not, however, completed

as NIDA withheld funding for the planned and approved Phase I and II protocols and sub-

sequently ended its ibogaine evaluation project in 1995. Nonetheless, the continuing use of

ibogaine for addictions treatment in the United States and around the world constitutes a

“vast uncontrolled experiment,” which when combined with the other kinds of studies

(case reports, preclinical toxicological evaluation, and initial Phase I trials of safety phar-

macokinetic; paraphrase from Alper and Lotosf, Volume II), provides a substantial body of

evidence constituting preclinical proof of concept (See Alper et al. 1999; Alper 2001;

Mash et al. 1998, 2001; Alper and Lotosf, Volume II).

11. See Abrams, this volume. To keep up with the latest developments in medical

marijuana, we recommend the groups listed in the concluding chapter of Volume 1 plus

the following: www.mpp.org, (Marijuana Policy Project) http://www.gwpharm.com/

research_pipeline.asp (G. W. Pharmaceuticals). If you search PubMed or other standard

scientiﬁc resources, try searching <cannabinoid>. — The Editors.

12. Material in this section liberally adopted from www.drugpolicy.org.

13. Material in this section liberally adopted from www.cognitiveliberty.org.

14. Material in this section liberally adopted from www.maps.org.

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298 PSYCHEDELIC MEDICINE: SOCIAL, CLINICAL, AND LEGAL PERSPECTIVES

Considerações sobre o tratamento da dependência por meio da ayahuasca

Article

Full-text available

Jan 2009

Este texto apresenta uma reflexão sobre o potencial terapêutico do uso ritual da ayahuasca no tratamento ao abuso de substâncias psicoativas em centros terapêuticos que combinam elementos da medicina e da psicologia ao uso da ayahuasca (no Brasil e no Peru), e nas religiões ayahuasqueiras e grupos neo-ayahuasqueiros no Brasil. São também discutidas perspectivas para uma futura agenda de pesquisas científicas interdisciplinares sobre este tema, refletindo sobre as possibilidades de diálogo entre biomedicina, antropologia e psicologia, além dos dilemas éticos e metodológicos envolvidos neste tipo de investigação.

Psychedelics as Medicines for Substance Abuse Rehabilitation: Evaluating Treatments with LSD, Peyote, Ibogaine and Ayahuasca

Article

Full-text available

Jan 2015

Michael James Winkelman

Substances known as psychedelics, hallucinogens and entheogens have been employed in ethnomedical traditions for thousands of years, but after promising uses in the 1950's and 1960's they were largely prohibited in medical treatment and human research starting in the 1970's as part of the fallout from the war on drugs. Nonetheless, there are a number of studies which suggest that these substances have potential applications in the treatment of addictions. While these substances are generally classified as Schedule I, alleging no established medical uses and a high drug abuse potential, there is nonetheless evidence indicating they might be safe and effective tools for short term interventions in addictions treatment. Evidence suggests that the psychedelics have a much greater safety profile than the major addictive drugs, having extremely low levels of mortality, and producing little if any physical dependence. This paper reviews studies evaluating the use of LSD, peyote, ibogaine and ayahuasca in the treatment of dependencies and the possible mechanisms underlying the indications of effectiveness. Evidence suggests that these substances help assist recovery from drug dependency through a variety of therapeutic mechanisms, including a notable "after-glow" effect that in part reflects their action on the serotonin neurotransmitter system. Serotonin has been long recognized as central to the psychedelics' well-known phenomenological, physical, emotional and cognitive dynamics. These serotonin-based dynamics are directly relevant to treatment of addiction because of depressed serotonin levels found in addict populations, as well as the role of serotonin as a neuromodulators affecting many other neurotransmitter systems.

The treatment and handling of substance dependence with ayahuasca: reflections on current and future research

Chapter

Full-text available

Jan 2010

This text presents a series of reflections on the therapeutic potential of the ritual use of ayahuasca in the treatment and handling of substance dependence problems. Anthropo-logical and psychiatric data on the ritual use of ayahuasca for 'healing' dependence in psy-chotherapeutic centers (in Peru and Brazil), as well as in ayahuasca religions (in Brazil), are reviewed and critiqued. Methodological, ethical and political considerations for current and future research in this area are then discussed, and an interdisciplinary agenda for studies on the use of ayahuasca to treat or handle substance dependence is proposed.

MDMA-Assisted Therapy: A New Treatment Paradigm for Autistic Adults with Social Anxiety.

Article

Full-text available

Mar 2015

The first study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of social anxiety in autistic adults commenced in the spring of 2014. The search for psychotherapeutic options for autistic individuals is imperative considering the lack of effective conventional treatments for mental health diagnoses that are common in this population. Serious Adverse Events (SAEs) involving administration of MDMA in clinical trials have been rare and non-life threatening. To date, MDMA has been administered to over 1133 individuals for research purposes without the occurrence of unexpected drug-related SAEs that require expedited reporting per FDA regulations. Now that safety parameters for limited use of MDMA in clinical settings have been established, a case can be made to further develop MDMA-assisted therapeutic interventions that could support autistic adults in increasing social adaptability among the typically developing population. As in the case with classic hallucinogens and other psychedelic drugs, MDMA catalyzes shifts towards openness and introspection that do not require ongoing administration to achieve lasting benefits. This infrequent dosing mitigates adverse event frequency and improves the risk/benefit ratio of MDMA, which may provide a significant advantage over medications that require daily dosing. Consequently, clinicians could employ new treatment models for social anxiety or similar types of distress administering MDMA on one to several occasions within the context of a supportive and integrative psychotherapy protocol. ClinicalTrials.gov Identifier: NCT02008396. Copyright © 2015. Published by Elsevier Inc.

Setting the Stage for the Inner Journey: Unraveling the Interplay of Contextual Factors and the Intensity of Ego-Dissolution in Naturalistic Psychedelic Experiences

Preprint

Full-text available

Jun 2024

Psychedelic substances have the potential to induce profound alterations in cognition, emotionality, and sensory perception. The quality and intensity of these subjective effects exhibit high intra- and inter-individual variability, which can potentially be accounted for by the variability in contexts in which psychedelics are used. Therefore, the aim of the present cross-sectional study was to investigate how contextual factors - both internal and external - are related to the subjective intensity of psychedelic experiences. Participants filled an online survey and reported their motivations for past use of a given substance, frequency of use in different environments and social contexts. Additionally participants filled the Ego Dissolution Inventory to evaluate the intensity of past ego-dissolution experiences. Robust linear regression analysis was performed on data from 862 psychedelic users (701 used LSD and 553 used psilocybin mushrooms) and revealed that participants consuming psychedelics for spiritual or self-healing purposes reported more intense ego-dissolution experiences, while those reporting curiosity as a motivation reported less intense ego-dissolution effects. However, the social context and physical environment did not exhibit robust associations with the reported ego-dissolution, suggesting that setting might not account for ego-dissolution in naturalistic users, or that its impact is more complex or nuanced. Therefore, our study improves understanding of how contextual factors are related to the acute psychedelic experiences in naturalistic context, and thus could contribute to improving harm reduction strategies and optimizing psychedelic-assisted therapies.

Therapeutic Applications of Ayahuasca and Other Sacred Medicines

Chapter

Full-text available

Nov 2014

Michael James Winkelman

Therapeutic applications of the psychedelics or hallucinogens found cross-culturally involve treatment of a variety of physical, psychological, and social maladies. Modern medicine has similarly found that a range of conditions may be successfully treated with these agents. The ability to treat a wide variety of conditions derives from variation in active ingredients, doses and modes of application, and factors of set and setting manipulated in ritual. Similarities in effects reported cross-culturally reflect biological mechanisms, while success in the treatment of a variety of specific psychological conditions points to the importance of ritual in eliciting their effects. Similar bases involve action on the serotonin and dopamine neurotransmitter systems that can be characterized as psychointegration: An elevation of ancient brain processes. © 2014 Springer-Verlag Berlin Heidelberg. All rights are reserved.

Treatment of Acute Opioid Withdrawal with Ibogaine

Article

Full-text available

Jul 1999
AM J ADDICTION

Ibogaine is an alkaloid with putative effect in acute opioid withdrawal. Thirty-three cases of treatments for the indication of opioid detoxification performed in non-medical settings under open label conditions are summarized involving an average daily use of heroin of .64 ± .50 grams, primarily by the intravenous route. Resolution of the signs of opioid withdrawal without further drug seeking behavior was observed within 24 hours in 25 patients and was sustained throughout the 72-hour period of posttreat-ment observation. Other outcomes included drug seeking behavior without withdrawal signs (4 patients), drug abstinence with attenuated withdrawal signs (2 patients), drug seeking behavior with continued withdrawal signs (1 patient), and one fatality possibly involving surreptitious heroin use. The reported effectiveness of ibogaine in this series suggests the need for systematic investigation in a conventional clinical research setting.

Regulation of the medical use of psychedelics and marijuana /

Article

Full-text available

Jan 2000

Rick Doblin

Granted by the Committee on Higher Degrees in Public Policy. Thesis (Ph. D.)--Harvard University, 2000. Includes bibliographical references.

Shamans, Sacraments, and Psychiatrists

Article

Full-text available

Jan 1989

This article reviews the role of psychedelic drugs as potential tools for psychiatric research and practice. The decline in the utilization of these substances is linked to social reactions, which led to psychedelics being scheduled as controlled substances and consequently unavailable for human research. Three different paradigms for the use of psychedelics in psychiatry are reviewed: the psychotomimetic, the psycholytic, and the psychedelic approaches. The psychotomimetic paradigm, which viewed hallucinogens as agents for temporarily inducing psychoses, proved to be of limited value to the understanding and treatment of mental illness. The psycholytic approach, which was derived from the psychoanalytic paradigm, is a technique employing low doses of psychedelic drugs to reduce psychological defenses and to release unconscious information. The high-dose psychedelic paradigm frequently produced reports of mystical or spiritual experiences, thus recasting the psychiatrist as the modern-day shaman. This paradigm has alienated many in the psychiatric profession and has led to a reaction against the use of psychedelics in psychotherapy. If the opportunity should arise to pursue sanctioned clinical research with these unique psychoactive substances, however, it will be imperative to learn from the traditional models of shamanic healers in order to optimally assess true clinical efficacy and safety.

LSD and psychotherapy

Article

Full-text available

Oct 1985

Richard Yensen

A review of the historical trends in LSD research clearly indicates that LSD and similar drugs are too powerful and unique in their psychological effects to be mistaken for and studied as just another group of psychotropic compounds. The importance of the theoretical understanding and expectations of the researchers in determining the subjective effects and results of LSD treatment is undeniable. In addition, double-blind controlled studies have been demonstrated to be an inappropriate methodology for studying LSD, because it is not feasible to create an effective blind for LSD with either an active or inactive placebo. It must be realized that when attempting to scientifically study such ephemeral and easily influenced processes as those involving human consciousness, methods of study may influence the process and outcome of the research. In 1937 Werner Heisenberg demonstrated the uncertainty principle in relation to any attempt to measure with accuracy the minute processes of electrons in the atom. One must consider the possibility that current tools and methods for studying the effects of LSD are presently so crude as to demonstrate a similar uncertainty principle in LSD research: The methods of measuring actually influence the process under study to such a degree that the results that are garnered are primarily the effects of attempts at measurement. The continuing crisis in psychiatric and psychological treatment demands that the most powerful of the psychoactive drugs cannot simply be shelved and forgotten. The need is too strong to advance knowledge of the role and function of the human mind in health and disease. LSD and similar drugs hold a tremendous promise for humankind if only ways can be found to further understanding of how to use them responsibly and appropriately. Perhaps other societies that have integrated these substances into the very fabric of their social order may offer models. As Silberman (1970) has written: "No approach is more impractical than one which takes the present arrangements and practices as given, asking only 'How can we do what we are doing more effectively?' or 'How can we bring the worst institutions up to the level of the best?' These questions need to be asked to be sure; but one must also realize that best may not be good enough and may, in any case, already be changing."

Methods in observational epidemiology

Article

Jan 1986

Drug tourism in the Amazon

Article

Jan 1994
Anthropol Conscious

M. Dobkin de Rios

Plants of the Gods

Article

Apr 1980

Realms of the Human Unconscious: Observations from LSD Research

Article

Dec 1976

Hallucinogenic drugs in psychiatric research and treatment

Article

Rj Strassman

Holistic Health and the Critique of Western Medicine

Article

Feb 1988

Janet McKee

The holistic view of health has been accurately criticized in the literature for its individualistic, victim-blaming ideology that obscures the social origins of illness. The paper explains how the contrasting view of the body and illness provided by the holistic model can help to show how Western medicine reflects the capitalist system in which it is promoted. It shows how evaluation of holistic therapies is problematic insofar as it is based on the analytical, reductionist criteria of the Western model. It suggests that one reason why holistic practices are not more fully accepted by Western medicine may be the challenge they pose to the Western model, and to the commodification of health needs promoted by this model.

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