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Culturally informed research design issues in a study for MDMA-assisted
psychotherapy for posttraumatic stress disorder
MONNICA T. WILLIAMS
1,2
*, SARA REED
1
and RITIKA AGGARWAL
3
1
Department of Psychology, University of Connecticut, Storrs, CT, USA
2
School of Psychology, University of Ottawa, Ottawa, ON, Canada
3
MAPS Public Benefit Corporation, Santa Cruz, CA, USA
(Received: May 1, 2019; accepted: June 13, 2019)
Recent research suggests that psychedelic drugs can be powerful agents of change when utilized in conjunction with
psychotherapy. Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been studied as a means of
helping people overcome posttraumatic stress disorder, believed to work by reducing fear of traumatic memories and
increasing feelings of trust and compassion toward others, without inhibiting access to difficult emotions. However,
research studies for psychedelic psychotherapies have largely excluded people of color, leaving important questions
unaddressed for these populations. At the University of Connecticut, we participated as a study site in a MAPS-
sponsored, FDA-reviewed Phase 2 open-label multisite study, with a focus on providing culturally informed care to
people of color. We discuss the development of a study site focused on the ethnic minority trauma experience,
including assessment of racial trauma, design of informed consent documents to improve understanding and
acceptability to people of color, diversification of the treatment team, ongoing training for team members, validation
of participant experiences of racial oppression at a cultural and individual level, examination of the setting and music
used during sessions for cultural congruence, training for the independent rater pool, community outreach, and
institutional resistance. We also discuss next steps in ensuring that access to culturally informed care is prioritized as
MDMA and other psychedelics move into late phase trials, including the importance of diverse sites and training
focused on therapy providers of color.
Keywords: MDMA, race, methodology, PTSD, racial trauma, psychedelic
INTRODUCTION
Posttraumatic stress disorder (PTSD) describes a constella-
tion of symptoms that can arise after experiencing or
witnessing a traumatic event. Individuals who have been
exposed to a traumatic event that causes a serious fear for
their own life or the lives of others is at risk of developing
PTSD, with those experiencing multiple traumas at higher
risk (Breslau, Chilcoat, Kessler, & Davis, 1999). People
typically affected include survivors of violent acts and
disasters, emergency responders to traumatic events, people
who experience the sudden death of a loved one, victims of
abuse, accident victims, and combat veterans (Kessler et al.,
2017).
However, many other events can be traumatic as well,
particularly to people of color (Williams, Printz, Ching, &
Wetterneck, 2018). African Americans, Hispanic/Latinx
Americans, and Native Americans are more likely to expe-
rience trauma related to experiences of police brutality,
community violence, racism, and poverty than their non-
Hispanic White counterparts (Pole, Gone, & Kulkarni,
2008;Williams, Printz, et al., 2018). Many immigrants and
refugees have PTSD from the impact of cultural trauma due
to ethnic cleansing and war, compounded by difficult
immigration experiences and adjustment-related stressors
(Bosson et al., 2017). Therefore, addressing the problem of
traumatization among these often marginalized ethnic
groups is an important goal for an equitable and healthy
society.
The Multidisciplinary Association for Psychedelic Stud-
ies (MAPS) and MAPS Public Benefit Corporation (MAPS
PBC) have been at the forefront of addressing PTSD by
working to make 3,4-methylenedioxymethamphetamine
(MDMA)-assisted psychotherapy into a legal prescription
medicine (Emerson, Ponté, Jerome, & Doblin, 2014). MAPS
is currently sponsoring Phase 3 clinical trials of MDMA as a
tool to assist psychotherapy for severe PTSD, with clinical
sites in the United States, Canada, and Israel. MDMA is also
known as “ecstasy”or “molly,”but those street drugs
frequently also contain unknown and/or dangerous adulter-
ants. In MDMA-assisted psychotherapy, pure MDMA is
administered only 2–3 times in conjunction with psychother-
apy, unlike most medications for mental illnesses, which are
often taken daily for several years (e.g., Mithoefer, Wagner,
Mithoefer, Jerome, & Doblin, 2011).
Studies suggest that MDMA can augment psycho-
therapeutic work to help improve symptoms of PTSD
* Corresponding author: Monnica T. Williams, PhD; School of
Psychology, University of Ottawa, 136 Jean-Jacques Lussier,
Vanier Hall, Ottawa, ON K1N 6N5, Canada; Phone: +1 613
562 5801; Fax: +1 613 562 5169; E-mail: mwilli25@uottawa.ca
This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License,
which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and
source are credited, a link to the CC License is provided, and changes –if any –are indicated.
© 2019 The Author(s)
ORIGINAL ARTICLE Journal of Psychedelic Studies
DOI: 10.1556/2054.2019.016
(e.g., Mithoefer et al., 2018). MDMA reduces the fear of
traumatic memories and increases feelings of trust and
compassion toward others without causing sensory distor-
tions or inhibiting access to difficult emotions. As such,
MDMA can increase the effectiveness of psychotherapy by
making traumatic memories more accessible and strength-
ening the alliance between therapist and client, making it an
important and promising new intervention for the treatment
of PTSD. In August 2017, the US Food and Drug Admin-
istration (FDA) granted “Breakthrough Therapy Designa-
tion”to MDMA-assisted psychotherapy for the treatment of
PTSD. This indicates that the FDA believes, based on Phase
2 data, that MDMA-assisted psychotherapy may have an
advantage over existing medications for PTSD, and it
signals their intent to expedite the review process for a
New Drug Application for MDMA (Burns, 2017).
However, there are still large gaps in the body of knowl-
edge surrounding MDMA. Although many communities of
color experience the highest rates of PTSD –leading to
prolonged suffering, disability, and poor quality of life
(e.g., Himle, Baser, Taylor, Campbell, & Jackson, 2009)–
they are extremely underrepresented in psychedelic research
(Michaels, Purdon, Collins, & Williams, 2018;Williams &
Leins, 2016). People of color have not been adequately
included in previous studies of MDMA-assisted psychother-
apy to determine if the treatment is appropriate, safe, or
effective for them. Research has been conducted mostly with
White participant samples, limiting the generalizability of
safety and efficacy findings for people of color, and leading
to their exclusion from MDMA’s potential therapeutic ben-
efits (e.g., Herzberg & Butler, 2019). Thus, lack of diversity
is an important ethical concern (Sisti, 2018).
CULTURALLY INFORMED ADAPTATIONS TO
MDMA-ASSISTED PSYCHOTHERAPY
At the University of Connecticut Health Center (UConn),
our team participated in a MAPS-sponsored, Phase 2 open-
label multisite study for PTSD (MP-16), under the guidance
of the FDA. This site was the only one focused on the
recruitment of ethnoracial minority participants meeting
criteria for PTSD. The site protocol emphasized culturally
sensitive and respectful treatment approaches for people of
diverse backgrounds, considering the impact of cultural
differences and the possible need to adapt MDMA-assisted
psychotherapy to the needs and culturally specific traumas
experienced by people of color. In this study, we discuss
some of methodological changes that were made to help
ensure that the MDMA research was culturally sensitive and
inclusive.
Diversification of the treatment team
Several studies have documented to have adequate staff
members from diverse groups as key to successful efforts at
recruitment and retention of people of color (Williams,
Tellawi, Wetterneck, & Chapman, 2013). One reason for
this is that many people of color fear or feel uncomfortable
with the mental health system (U.S. Department of Health
and Human Services, 1999). Anecdotal reports from people
of color reveal fear and uncertainty from White therapists
over the ability to support the complexity of their emotional
experience, and indeed, several potential participants
expressed gratitude, safety, and comfort when interacting
with our therapists of color, as they had experienced dis-
connects with White clinicians in the past. It can make a
critical difference in participation, willingness, and overall
participant comfort when members of the research team
represent participant diversity. It makes the outcome of the
study more personally relevant when participants see others
like themselves invested in the research program and occu-
pying key leadership roles (e.g., Williams, Proetto, Casiano,
& Franklin, 2012), and participants may feel less worried
about experiencing racism when they see other people of
color involved. Furthermore, having clinicians from differ-
ent ethnic groups improves the ability of the team as a whole
to understand and appreciate issues relevant to a greater
number of potential participants.
At UConn, we intentionally made our research team as
diverse as possible. This included the Principal Investigator
(PI; an African American female psychologist), the co-PI (a
White American male psychiatrist), the study coordinator (an
African American female marriage and family therapist), the
study physician (an Indian American male), and three addi-
tional study therapists that included a Singaporean Chinese
male, biracial African American female, and a Hispanic
Asian American male. Our team was also diverse in terms
of sexual identity, age, religious beliefs, clinical training, and
therapeutic orientation. By sharing each other’s experience
and perspectives, this diversity enabled us to effectively work
with a range of clients with several different ethnic and
intersecting identities.
Outreach and recruitment
Most of the sites in the MAPS PBC MDMA-assisted
psychotherapy studies are contacted directly by prospective
participants as a result of information posted on the clinical
trials registry (clinicaltrials.gov) and e-mail announcements
from MAPS. However, these potential participants tend to
have a preexisting interest in the study due to something
they saw in the media or a previous connection with
psychedelic communities, which are, with few exceptions,
mostly White. As a result, the information about the study
was not being adequately disseminated to communities of
color.
Although MAPS PBC, the designated clinical trial orga-
nizer, had preapproved language for recruitment materials,
as shown in Figure 1, it was inadequate for attracting people
of color. Unlike the White participants who were flooding
the study lines at all sites, our target audience required a
different approach, which included building trust, psychoe-
ducation, and gentle encouragement. The approved text did
not address the concerns of our participants of color, such as
fears of research abuse and safety of the drug. Due to our
country’s long history of research abuses against people of
color (Suite, La Bril, Primm, & Harrison-Ross, 2007),
minimal information could make potential participants
believe that study sponsors were hiding things from them
2|Journal of Psychedelic Studies
Williams et al.
and generate increased suspicion about the researchers’
intentions.
MAPS PBC was not amenable to investing time and funds
into creating new ads that would attract people of color when
the existing methods seemed to be generating more than
enough participants. To fill this gap, for the next phase of the
study, our site created its own flyer to target these underrep-
resented groups, based on the literature and our own past
experience with minority outreach efforts. As shown in
Figure 2, the new ad included several vital elements including
(a) names and pictures of study staff; (b) diverse and
well-qualified team leaders; (c) psychoeducation about PTSD
and common causes of trauma among people of color;
(d) language addressing fears of death, disability, and addic-
tion; and (e) language about our site’s culturally sensitive and
respectful treatment approach (Avery, Hernandez, & Hebl,
2004;Williams, Proetto, et al., 2012). Such ads can be used
for campus posters, public transportation, handouts, web
pages, and e-mail outreach.
However, ads alone are not usually sufficient to generate
adequate interest in a research study, particularly a poten-
tially controversial one that included a psychedelic drug.
The literature and our own experience indicated that word of
mouth from trusted sources is one of the most powerful
recruiting tools for research studies (Williams, Beckmann-
Mendez, & Turkheimer, 2013). As such, community out-
reach is an important part of a successful recruitment effort,
and study personnel can help by making and maintaining
personal connections with important people and organiza-
tions within communities of interest. At UConn, our team
gave several talks both on and off campus. On campus,
lectures were co-sponsored by Students for Sensible Drug
Policy who partnered with Collective Uplift, an organization
for student athletes of color. The topics of the talks were
intended to be engaging and relevant to students in these
organizations; lectures included “From Microaggressions to
Hate Crimes: #RacialTraumaIsReal,”given by the PI, and
“MDMA-Assisted Psychotherapy: Our Experiences as Sub-
jects in an FDA-Approved Clinical Trial,”given by two of
the study therapists who participated in a healthy volunteer
study sponsored by MAPS (e.g., Ching, in press). Each of
these talks generated a number of interested potential parti-
cipants of color from those who had attended the event as
well as interest from their friends and families. When giving
such talks, study personnel can provide flyers for people to
take home and share, such as those in Figure 2.
It should be noted that some of the unsolicited e-mails we
received from participants were from people of color, but
there was no way to know this since most participants did
not disclose their race or ethnicity in their initial e-mails
to us. One strategy that helped was to include an auto-reply
e-mail that acknowledged receipt of the potential partici-
pant’s e-mail and asked them to respond by e-mail with
specific demographic information, including their race/
ethnicity, as well as other demographics such as age, city
of residence, and current medications. This strategy is cur-
rently in use at several of the Phase 3 sites to more efficiently
identify racially and ethnically diverse participants.
Compensation
People of color are more likely to be economically disad-
vantaged, making it more difficult to participate, as the time
spent in a research study may be outweighed by other
responsibilities, such as a job, school, or taking care of a
family (Fisher et al., 2002). Therefore, it is important to
provide meaningful and adequate compensation to partici-
pants for their time and to show appreciation for their
participation (Williams, Tellawi, et al., 2013). Furthermore,
friends and family members may be suspicious of research,
or in the case of mental health specifically, consider it a
luxury, and pressure participants of color not to participate.
Incentives can help persuade others in the participant’s
circle that the participant’s time is being respected and the
study is worth conducting. Although there may be concerns
about increased study costs, the funds that go toward
compensating participants are actually a very small percent-
age of the study budget overall, and such incentives facili-
tate participation of low-income and economically disad-
vantaged individuals of all racial groups.
Because of the great interest by White participants,
initially there did not appear to be a need to financially
compensate participants. However, we believe that all par-
ticipants should be fairly compensated as a matter of social
justice. That being said, payments that are too large can
amount to coercion and thus the appropriate amount should
be carefully considered (Grady, 2005). At certain approved
sites, MAPS was able to provide a total of $400 to
Do You Have Posttraumatic Stress Disorder (PTSD)?
Figure 1. Original IRB-approved ad for MDMA-assisted psychotherapy study for PTSD
Journal of Psychedelic Studies |3
Culturally informed research design in study of MDMA for PTSD
participants –$100 for each overnight visit and $100 for the
independent rater assessments (This is explained in more
detail in the section “Training for independent raters.”). This
greatly facilitated participation as several of our participants
were low income or students. Compensation should be
provided in cash whenever possible, as a check can be a
dilemma if participants do not have checking accounts,
which was the case for some of our participants.
Figure 2. Sample recruitment flyer. A colorful flyer, originally designed for future Phase 3 studies, illustrates important design elements that
are key for attracting people of color
4|Journal of Psychedelic Studies
Williams et al.
Initial screening
For the initial screening, clinicians need to obtain detailed
information from potential participants by phone with very
little time to build rapport. Given that many participants of
color are mistrustful of the medical system, and even more
so a medical research study, extra effort needs to occur to
create trust. Often people of color have not felt respected or
been given the same courtesy that most of the White
participants have taken for granted in medical contexts
(Maina, Belton, Ginzberg, Singh, & Johnson, 2016), and
so they may be understandably wary of study clinicians.
Furthermore, people of color generally like to get to know
people before opening up, which can make it difficult to
elicit important trauma details at first contact. Moreover,
people of color generally have a lower mental health
literacy, due to greater cultural stigmas about mental health;
therefore, study screening staff may need to provide psy-
choeducation about symptoms to aid in determining eligi-
bility (Cheng, Wang, McDermott, Kridel, & Rislin, 2018;
Williams, Domanico, Marques, Leblanc, & Turkheimer,
2012).
At the UConn site, we deliberately dedicated more time
to talking to potential participants during phone screenings.
Although this task was often performed by the study
coordinator at other sites, we shifted to having the potential
therapy providers make some of these calls to help them
build rapport sooner. Therapists spent more time explaining
PTSD symptoms to potential participants, or in some cases
translating their descriptions of symptoms into terminology
more consistent with DSM-5. Finally, therapists used this
opportunity to collect or confirm details about the person’s
racial and ethnic identity to determine if the individual’s
participation would help meet our site’s critical diversity
goals.
Informed consent
The consent form is vitally important as it is a formal
description of what the study entails. However, sometimes
the document is misunderstood due to language that can be
unnecessarily off-putting or frightening. As such, a change
of language in consent forms was needed to make them
more palatable for people of color. For example, use of the
term “research”was minimized in favor of less triggering
terms such as “project”and “study”to distance these
recruitment efforts from associations with historical research
abuses against African Americans (Williams, Tellawi, et al.,
2013). For Latinx people, the word “investigation”can be
triggering to those who face immigration stigma, so that was
similarly reworded. “Experimental session”was changed to
“overnight test session”to eliminate terms that may make
participants further question their safety.
Researchers should also anticipate that more time will be
needed to review paperwork with participants. They should
make the process as conversational as possible to help put
participants at ease. Because the informed consent docu-
ment may resemble a contract, it is important to emphasize
that participants are not signing away their rights, but rather
the consent form exists to ensure that clinicians are doing
their jobs by providing complete information about what to
expect; participants are still free to withdraw at any time. As
researchers begin to create a shared language with partici-
pants, space opens for participants to ask more questions
about psychedelics, and this is a good opportunity to provide
this education about psychedelics and debunk any myths
they may believe.
It is important to review basic safety information, as that
will be one of the participant’s primary concerns. Partici-
pants of color are already wary for a number of reasons
previously discussed and do not want to hear extreme details
on everything that can go wrong –they are already worried
about this and have decided to move forward anyway.
Their main concerns about MDMA are fears of death,
physical disability, mental disability, and addiction (Rigg
& Lawental, 2018), and so clinicians should focus on the
track record to date for MDMA in these areas. Here, it
would be important to give honest information –that no one
who has taken MDMA in similar studies has died, become
disabled, or become addicted (e.g., the MDMA Investiga-
tor’s Brochure; Vizeli & Liechti, 2017). Giving exact
numbers helps promote trust and puts risks into perspective.
Setting and music
Set and setting refer to the non-drug factors, like mindset
and physical surroundings that shape psychedelic experi-
ences. People across cultures have been mindful of these
factors in psychedelic healing practices for a very long time
(Neitzke-Spruill, this issue). Therefore, it is critical to take
stock of the messages implicit in the setting provided for
participants. Individuals are part of a social context, which
refers to the immediate physical and social setting in which
people live or in which something happens or develops. It
includes the person’s culture and the people and institutions
with whom they interact. Given the importance of social
context, there are many facets to be considered when
creating a comfortable space, which differs by culture.
Because of the deeply entrenched and pervasive racist
messages embedded in nearly every social structure, delib-
erate measures may be needed to create a welcoming venue.
For example, a lack of diversity in artwork, reading material,
and decorations may communicate threat to people of color
(e.g., Purdie-Vaughns, Steele, Davies, Ditlmann, & Crosby,
2008). When creating ambiance, clinicians should consider
the décor of the facility –color schemes, choice of magazines,
and cultural office artwork can all be critically important in
making clients feel safe and welcome (Williams, Beckmann-
Mendez, et al., 2013).
A great deal of care and forethought went into the décor
of our study room at UConn, and input was solicited from all
members of the team. In terms of artwork, on one wall hangs
a framed print of a Latina mother holding her baby and on
another an impressionist map of the world in multicolor.
Other decorations include jade beads, a Tibetan sound bowl,
and colorful cotton throws and pillows with patterns from
India. As these decorations were reflective of the varied
cultures of the team, they brought an element of cultural
authenticity to the milieu. However, as noted, setting
encompasses more than simply décor.
Since before the advent of Western psychedelic thera-
pies, music has played an important role within the
Journal of Psychedelic Studies |5
Culturally informed research design in study of MDMA for PTSD
therapeutic framework as a way to provide support through-
out the session (Bonny & Pahnke, 1972). There is growing
research to indicate that music can help facilitate psyche-
delic experiences that are beneficial and important
therapeutically, and that listening to music while taking a
psychedelic medicine can evoke and intensify emotions
such as wonder, transcendence, power, tenderness, peace-
fulness, nostalgia, and joy (e.g., Kaelen, Roseman, Kahan,
Santos-Ribeiro, & Orban, 2016). In addition, music and
song are the integral part of many indigenous psychedelic
traditions (e.g., the icaros sung by shamanic healers during
the traditional ayahuasca ceremony; Labate & Pacheco,
2010;Tafur, 2017). In one study of 19 patients undergoing
psychedelic therapy with psilocybin for depression, analy-
ses revealed that the music had both “welcome”(desirable)
and “unwelcome”(aversive) influences on the patient’s
experience (Kaelen, Giribaldi, Raine, & Evans, 2018). In
many cases, it evoked deeply meaningful, emotional, and
therapeutically valuable emotions and imagery. In some
cases, however, this was not the case; 6 out of 19 patients
referred to “misguidance”and 9 out of 19 spoke to “resis-
tance”as being a part of their experience at some point
(Kaelen et al., 2018). However, to date, no empirical
research has been conducted to examine the role of music
in psychedelic-assisted therapy with people of color.
Music is strongly connected to culture, and it makes
sense that music conducive to psychedelic healing for White
Americans may be inadequate for those from other cultural
traditions. Therefore, it is important to consider potential
alterations, supportive measures, or alternatives to the typi-
cal Western playlist (e.g., new age music, space music, folk,
post rock, etc.) that will better suit the individual needs of
each patient based on their preferences, safety needs, age,
and rich cultural background and heritage. At our site, we
carefully tailored the playlist to the relevant demographic
and cultural factors of our participants to help optimize their
experience. As psychedelic therapy expands from research
labs and into more clinics, we hope that more therapists will
explore novel ways of incorporating music into psychedelic
therapies with the diversity of individuals and cultural
groups in mind.
Training for team members
It is of the utmost importance that study personnel have a
genuine commitment to the mental health of people of color
and have been properly trained in culturally informed
assessment and treatment techniques. Although most new
clinicians are now receiving some sort of diversity education
in training programs to increase awareness, practical skills
may not have been included. In addition, previous genera-
tions of clinicians may have received no diversity training at
all, leaving them ill equipped to work with people of color.
At UConn, therapists were trained to take a multicultural
approach to treatment, whereby the differences, strengths,
and uniqueness of each ethnoracial group were embraced.
All therapists participated in an 8-week diversity training
where they learned to better understand and connect with
people of color using Functional Analytic Psychotherapy
(FAP; Tsai et al., 2009). Although FAP can be used as a
standalone treatment for relationship issues, it is typically
used in combination with other therapies to help increase
engagement and strengthen rapport. The FAP training pro-
vided an experiential approach for recognizing and combat-
ing personal biases, and therapists learned how to respond to
racially charged material in an empathetic rather than de-
fensive or dismissive manner (Miller, Williams, Wetterneck,
Kanter, & Tsai, 2015). Therapists were also educated on
microaggressions, including how to recognize and manage
them in interactions. These trainings did not replace the non-
directive, inner focused therapy that was required as per the
MAPS PBC study protocol (Mithoefer, 2015), but rather
augmented that approach.
Through a justice-oriented framework, our therapists
provided an environment of openness, curiosity, and vali-
dation for our participants’racialized experiences. This
included expressing empathy for experiences of racism and
marginalization with verbal and non-verbal cues. It also
included validating any mistrust of the research process, and
acknowledgment of historical research abuses against peo-
ple of color. All therapists were well aware of structural
racism typically embedded in current research processes and
vocalized their commitment to doing things differently. As
part of the conversation during initial visits, our therapists
might say something like, “One reason this site is committed
to working with people of color is because almost all
research to date has been done with White people. They
have been getting this treatment for years, and it’s time that
people like us are included too. Otherwise, how do we even
know if this treatment makes sense for us and our communi-
ties? Your involvement will help move this work forward for
everyone, and in the process you will receive a culturally-
informed treatment experience.”
Finally, cultural humility was emphasized throughout.
Despite the diversity of our team, we could not be equipped
for every ethnic and cultural group that contacted us, so we
needed to be sure not to ever become complacent in our
efforts or stop learning. Cultural humility is an approach that
communicates attentiveness and interest in the other person,
marked by openness, curiosity, lack of arrogance, and
genuine desire to understand clients’cultural identities
(Mosher et al., 2017). Therapists with high levels of cultural
humility rarely assume competence, but rather approach
clients with respectful openness and collaboratively explore
the client’s cultural identities. In this regard, cultural com-
petence should be viewed as a journey, not a destination, as
we are always becoming more culturally competent while
never actually achieving cultural competence. Cultural com-
petence is a dynamic ever-changing and ever-challenging
lifelong process (Yeager & Bauer-Wu, 2013).
Assessing racial trauma
When traumatization results from experiences of racism, it
is sometimes called racial trauma. It can be caused by
major experiences of racism such as workplace harassment
or police brutality, or it can be the result of an accumulation
of many small occurrences, such as everyday discrimina-
tion and microaggressions (e.g., Williams, Kanter, &
Ching, 2018). One difficulty is that clinicians may only
recognize racism as trauma when an individual experiences
a specific racist event, such as a violent hate crime
6|Journal of Psychedelic Studies
Williams et al.
(Malcoun, Williams, & Bahojb-Nouri, 2015). This is limiting
given that many people of color experience cumulative
experiences of racism as traumatic (Butts, 2002). In addition,
people of color may not share experiences of discrimination
when asked about traumas they may have experienced unless
they are told explicitly that racism counts as a trauma
(Williams, Metzger, Leins, & DeLapp, 2018).
To ensure that traumas due racism and to other forms
of oppression were captured, a modified version of the
UConn Racial/Ethnic Stress & Trauma Survey (UnRESTS;
Williams, Metzger, et al., 2018) was added to the source
documents used for collecting information about participants
by study therapists. The UnRESTS is a semi-structured
interview designed to assess racial trauma in clients who are
part of stigmatized ethnic and racial groups. The UnRESTS
collects information about a client’s ethnic identity and then
guides the clinician to ask about experiences surrounding:
(a) explicit and obvious racism, (b) discrimination experi-
enced by loved ones, (c) vicarious prejudicial experiences
that were learned about, and (d) experiences with subtle forms
of racism or microaggressions. The scope of the measure was
broadened to include other types of discrimination, including
“gender, sexual orientation, age, disability, faith, or a combi-
nation of reasons,”and it was shortened from its original
length to minimize participant burden. This information is
also provided to the independent raters so they know about
the participants’experiences as well. Feedback from clin-
icians at various MAPS PBC study sites found the measure
easy to use and useful in better understanding their partici-
pants’histories of racial trauma and other forms stigmatiza-
tion. Even in cases where experiences of discrimination did
not meet DSM-5 Criterion A, the information was useful for
better understanding participants’lived experiences (see
“Supplementary Material”for the short version of the
UnRESTS).
Training for independent raters
The independent raters for the MDMA-assisted psychother-
apy for PTSD study are gatekeepers in a sense, as they
quantify the PTSD diagnosis for participants, which must
meet a certain threshold before being allowed to enroll.
Using the gold standard in PTSD research, the Clinicians
Administered PTSD Scale (Weathers et al., 2013), the
independent rater group is a pool of highly trained clinicians
who are not present during therapy to minimize bias during
outcome measurements.
As with study therapy providers, participants of color
may not initially trust raters, thereby requiring raters to
develop a quick positive rapport with participants, so they
feel safe enough to disclose their traumas. Furthermore,
raters needed to be able to identify sources of trauma related
to the experience of racial discrimination and related forms
of oppression. However, the vast majority of MAPS PBC
independent raters were White and many had inadequate
training in working with people of color. Since the study
design required that participants receive their rater from the
pool randomly, it was not possible to provide an ethnic
match for participants of color or even make a rater recom-
mendation to ensure that the clinician was well-trained in
working with people of color.
To address these issues, more raters of color were hired
and all raters received a diversity training designed in part
by the first author (MTW) to better assess clients across
racial, ethnic, and cultural differences. This included regular
meetings online as a group where raters were provided
readings and presentations on the topics of ethnic identity
development, therapeutic distance based on ethnic identity;
models of acculturation; Whiteness and privilege; racism
and microaggressions; racial trauma, personality disorders,
and culture; and cultural issues surrounding the use of study
measures. These trainings were video-recorded and are now
required viewing for MAPS PBC therapy providers partici-
pating in Phase 3 studies, which extends the benefits of this
training study-wide. In addition, two short quizzes were
developed by the third author (RA) that allowed therapy
providers to reflect on the material presented.
Independent raters also completed challenging experien-
tial homework exercises designed to facilitate a shift in
thinking from an ethnocentric to a multicultural perspective.
This involved practicing mutually reciprocal interactions
with others across race, practicing giving the UnRESTS,
self-reflection, and sharing challenges in the group. Similar
techniques have been empirically shown to improve client-
clinician interactions (Rosen et al., 2018). The raters learned
much from this training and felt better equipped to work
with diverse participants (see “Supplementary Materials”
for questions used to help assess rater cultural competency).
Even so, this situation was not perfect –a Caribbean woman
who was selected to be a part of the trial dropped out of
screening because she did not receive a Black woman as her
rater.
Institutional resistance
Despite initial displays of enthusiasm about the study by
university leadership, there was some fear and misunder-
standing surrounding safety issues related to MDMA. This
led to unreasonable levels of precaution, far greater than
warranted based on MDMA’s safety record and exceeding
what was required by the FDA. Although the study was
designed and approved for an outpatient setting, the institu-
tion’sOffice of the Vice President of Research (OVPR)
insisted the study to take place in the hospital, which added
greatly to the level of bureaucracy, complexity of study
billing, and study costs (Lekhtman, 2018). On several
occasions, the health center demanded the employment of
a nurse as a night attendant instead of a volunteer, as is
typically done at other study sites. We opted to use a clinical
graduate student as a night attendant (with the study physi-
cian and PI on call), as a nurse was unnecessary and would
have been cost prohibitive.
There was notable structural, institutional, and individual
racism that also impeded the work, as well as bureaucratic
obstacles. This included untenable delays in hiring essential
personnel, including 5 months to officially hire the study
coordinator. The PI had to meet with the OVRP and the
Chief Diversity Officer to overcome this resistance, and
once hired, the institution refused to provide the study
coordinator with her back pay, even though the sponsor
had already provided these funds to the university. We were
able to resolve this by having the sponsor pay the study
Journal of Psychedelic Studies |7
Culturally informed research design in study of MDMA for PTSD
coordinator to back pay directly. Other barriers included
refusal to provide promised billing services, refusal to give
prescribing privileges to our team’s psychiatrist (a Harvard-
trained MD–PhD), twice having our study space given away
to another research team, study staff being harassed by
nurses for “not belonging”in our research space, an aggres-
sive audit of the study that took 2 months of staff time (and
included several inaccurate findings of misconduct that were
later withdrawn), opposing the PI’s plans to move the study
to a more collegial health center division, and inappropriate
threats by the OVPR for exploring the possibility of moving
the study off-campus.
In terms of sexism, female clinicians felt ignored and not
taken seriously by health center staff and UConn leadership.
For example, there were several meetings by chairs, deans,
and vice presidents about study issues and in every case the
female PI (MTW) was not invited, despite repeated requests
for inclusion; rather she was informed about decisions
impacting the study after the fact, without the benefitof
her knowledge and input at those meetings.
There were other problematic issues as well, such as
higher than normal charges by the health center for medical
procedures, in some cases three times the typical rate
(e.g., the health center charged the sponsor $3,820 for a
nuclear stress test while charging Anthem only $837 for this
same test). In this case, we were able to contract with a less
expensive outside clinic for needed cardiac tests.
DISCUSSION
Implications for Phase 3 trials
In this study, we have outlined several key issues and
strategies surrounding participation and retention of people
of color into MDMA-assisted psychotherapy studies. Im-
portant considerations include a diverse study staff, pur-
poseful training in cultural competence for therapists and
raters, targeted outreach for recruitment, meaningful incen-
tives, a comfortable setting, and competent assessment of
racial trauma. Critical discussion on limitations and obsta-
cles to recruiting diverse populations is important to conduct
during protocol development. It is worth noting that involv-
ing someone with expertise in culturally informed research
methods at the front end, before protocols were developed,
would have prevented some of the methodological issues
that needed to be changed after the fact. There is also a
need to confront institutional and individual biases that may
work against inclusion, as racism and sexism are embedded
into nearly all institutional structures and systems (Salter,
Adams, & Perez, 2018). For example, currently, MAPS
PBC staff includes only 4 people of color out of 26.
Recognizing the benefits of a diverse staff, the organization
is in the process of hiring with the intention of increasing
diversity, particularly in the upper echelons of the
organization.
The methods described herein were effective for recruit-
ment and retention at our site in Connecticut but each
community has its own differences and nuances, which will
require an ongoing review of efforts to determine if diversity
goals are being met. Holding regular team meetings to
review enrollment rates versus targeted enrollment numbers
can inform team leaders as to if diversity goals are being
met. A self-correcting process should be implemented
whereby methods that are not effective are reduced and
those that are effective are retained or increased (Clay, Ellis,
Amodeo, Fassler, & Griffin, 2003).
MAPS PBC is currently running Phase 3 trials, and
although the UConn site was not included due to lack of
adequate institutional support at the health center (Lekhtman,
2018), many of the modifications made to study protocols
continue to benefit other sites and the study as a whole, such
as the changes to consent forms, trainings for raters, and
training materials for therapy providers. However, people of
color are underrepresented as clinicians at most sites, so work
is still needed to make participants of color feel included,
welcome, safe, and understood. As a result, there may be less
than representative proportions of participants from various
ethnoracial groups in the final sample. If the final Phase 3
sample does not contain enough patients of color for mean-
ingful subgroup analyses, an additional study focused on
people of color would be an important next step to help
determine the safety and efficacy of MDMA-assisted psy-
chotherapy for people in underrepresented racial and ethnic
groups.
Expanded Access
Expanded Access is an FDA program that allows the use of
an investigational drug under an approved treatment proto-
col. The program is designed to address urgent and life-
threatening conditions in patients who do not adequately
respond to available treatment options. MAPS PBC has
recently applied for the Expanded Access program and
hopes for approval in 2019. If Expanded Access is ap-
proved, new sites in the US will be able to participate in their
Expanded Access protocol, which would allow the provi-
sion of open-label MDMA-assisted psychotherapy for
PTSD. Qualified sites will be required to have a team of
therapy providers, a physician, a study coordinator, and a
facility suitable to conduct MDMA-assisted psychotherapy,
with approval by regulatory agencies and under supervision
of MAPS PBC. Furthermore, therapy providers must be
trained through the MAPS Therapy Training Program to be
eligible to provide therapy, and this training and supervision
process costs approximately $9,000 per therapist. Expanded
Access clinics can utilize the methods described here to
increase inclusion of patients of color. That being said, due
to the extensive site and provider requirements, the cost for
an entire course of treatment will be unaffordable for many
people (current estimates are approximately $15,000), and
so work is needed to make this treatment accessible to those
with limited financial means.
As of 2018, MAPS PBC trained 221 MDMA therapists,
and only 22 (<10%) of these are therapy providers of color,
which included international therapy providers. More thera-
pists of color are sorely needed to bring MDMA treatment to
communities of color during the Expanded Access period
and thereafter. To this end, MAPS PBC is co-sponsoring an
MDMA therapy training for communities of color, grant-
funded by Open Society Foundations, Riverstyx Founda-
tion, Libra Foundation, and others sponsors. This training
8|Journal of Psychedelic Studies
Williams et al.
will equip therapists and inform community leaders of color
about this new modality and its ability to reduce symptoms
of PTSD, with a focus on culturally informed psychedelic
therapy. In the process of developing this training, the
standard MAPS PBC trainings will also benefit, as many
culturally informed updates will be available to add into it.
In addition to the standard 6.5-day training, this special
training will feature a 1.5-day opening workshop entitled,
“Psychedelic Medicine and Cultural Trauma.”Community
leaders will join therapy providers to engage in dialogue
about the social, political, cultural, and historical causes of
trauma, as well as a history of indigenous practices of
healing with plant medicines. This workshop will discuss
barriers to acceptance of MDMA therapy in communities of
color and potential ways forward. Most importantly, this
training will help build a community of color dedicated to
bringing MDMA therapy to communities to support its
members to both flourish and expand.
Future psychedelic therapists
Leaders in the field of psychedelic medicine are working to
develop credentialing boards to implement the therapeutic
competencies needed to work responsibly with MDMA
and other psychedelic substances. Because of the impor-
tance of this work and the extreme vulnerability of patients
during non-ordinary states of consciousness, all therapy
providers and supervisors should have basic competencies
in working ethically and skillfully with people of color
(Phelps, 2017;Sisti, 2018). These essential skills include
the ability to (a) understand normal cultural variations in
the expression of psychopathology and personality traits;
(b) identify trauma related to the experience of racial
discrimination, ethnic violence, xenophobia, and other
forms of oppression; (c) develop good rapport with people
of color by appropriately expressing caring, empathy, and
respect; (d) comfortably engage in discussions about ra-
cially charged topics; and (e) identify and describe their
own biases as they relate to ethnic and racial differences,
with an ongoing action plan to address these. All therapy
providers conducting psychedelic therapies should be
trained and tested in these areas prior to certification (also
see “Supplementary materials”for assessing cultural
competency).
CONCLUSIONS
A culturally informed approach in psychedelic therapies can
and should be used in the research process to ensure equity
and diversity in access to the potential benefits of MDMA.
Current processes for recruitment and treatment are not
sufficient to open the doors of psychedelic therapies to
people of color in the US or internationally (Michaels
et al., 2018). MAPS has been a leader in conducting research
into MDMA-assisted therapy and to our knowledge has
been the first to make a deliberate effort to include of people
of color in the work. Still more work is needed and
hopefully this trajectory of inclusion will continue as other
groups begin the work of ensuring that psychedelic research
meets the needs of everyone.
Acknowledgements: The authors would like to thank Mul-
tidisciplinary Association for Psychedelic Studies (MAPS)
for support of the study “An Open-Label, Multi-Site Phase 2
Study of the Safety and Effect of Manualized MDMA-
Assisted Psychotherapy for the Treatment of Severe Post-
traumatic Stress Disorder (MP-16).”They would also
acknowledge the Open Society Foundations (OSF), Libra
Foundation, Riverstyx Foundation, and others for grant
funding for “MDMA Therapy Training for Communities of
Color.”In addition, they would acknowledge Chad Wetter-
neck for providing diversity training and materials for the
MAPS rater pool, Alli Feduccia for her comments on the
manuscript, and Jennifer Purdon for help with the literature
search.
Conflict of interest: All authors report no conflicts of
interest.
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