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A Cross-Sectional Study of Cannabidiol Users

Authors:
  • The Center for Medical Cannabis Education

Abstract and Figures

Introduction: Preclinical and clinical studies suggest that cannabidiol (CBD) found in Cannabis spp. has broad therapeutic value. CBD products can currently be purchased online, over the counter and at Cannabis-specific dispensaries throughout most of the country, despite the fact that CBD is generally deemed a Schedule I controlled substance by the U.S. Drug Enforcement Administration and renounced as a dietary supplement ingredient by the U.S. Food and Drug Administration. Consumer demand for CBD is high and growing, but few studies have examined the reasons for increasing CBD use. Materials and Methods: A self-selected convenience sample (n = 2409) was recruited via an online survey designed to characterize whom, how, and why individuals are currently using CBD. The anonymous questionnaire was accessed from October 25, 2017 to January 25, 2018. Participants were recruited through social media. Results: Almost 62% of CBD users reported using CBD to treat a medical condition. The top three medical conditions were pain, anxiety, and depression. Almost 36% of respondents reported that CBD treats their medical condition(s) “very well by itself,” while only 4.3% reported “not very well.” One out of every three users reported a nonserious adverse effect. The odds of using CBD to treat a medical condition were 1.44 (95% confidence interval, 1.16–1.79) times greater among nonregular users of Cannabis than among regular users. Conclusion: Consumers are using CBD as a specific therapy for multiple diverse medical conditions—particularly pain, anxiety, depression, and sleep disorders. These data provide a compelling rationale for further research to better understand the therapeutic potential of CBD.
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Open Access
A Cross-Sectional Study of Cannabidiol Users
Jamie Corroon
1,2
and Joy A. Phillips
3
Abstract
Introduction: Preclinical and clinical studies suggest that cannabidiol (CBD) found in Cannabis spp. has broad
therapeutic value. CBD products can currently be purchased online, over the counter and at Cannabis-specific
dispensaries throughout most of the country, despite the fact that CBD is generally deemed a Schedule I con-
trolled substance by the U.S. Drug Enforcement Administration and renounced as a dietary supplement ingre-
dient by the U.S. Food and Drug Administration. Consumer demand for CBD is high and growing, but few studies
have examined the reasons for increasing CBD use.
Materials and Methods: A self-selected convenience sample (n =2409) was recruited via an online survey
designed to characterize whom, how, and why individuals are currently using CBD. The anonymous question-
naire was accessed from October 25, 2017 to January 25, 2018. Participants were recruited through social media.
Results: Almost 62% of CBD users reported using CBD to treat a medical condition. The top three medical con-
ditions were pain, anxiety, and depression. Almost 36% of respondents reported that CBD treats their medical
condition(s) ‘‘very well by itself,’’ while only 4.3% reported ‘‘not very well.’’ One out of every three users reported
a nonserious adverse effect. The odds of using CBD to treat a medical condition were 1.44 (95% confidence
interval, 1.16–1.79) times greater among nonregular users of Cannabis than among regular users.
Conclusion: Consumers are using CBD as a specific therapy for multiple diverse medical conditions—particularly
pain, anxiety, depression, and sleep disorders. These data provide a compelling rationale for further research to
better understand the therapeutic potential of CBD.
Keywords: cannabis; cannabidiol; CBD; marijuana; pain; anxiety
Introduction
Cannabidiol (CBD) is one of more than a hundred can-
nabinoids found in Cannabis sativa L(Cannabis
spp. or Cannabis), a plant more well known colloqui-
ally as marijuana and hemp. CBD is typically the sec-
ond most abundant cannabinoid found in Cannabis
after tetrahydrocannabinol (THC).
1
CBD was first iso-
lated in 1940 and characterized structurally in 1963.
2,3
CBD is well tolerated in humans and maintains a
good safety profile.
4,5
Neither abuse nor dependence
has been demonstrated.
5
In preclinical studies, CBD
shows potential therapeutic efficacy against a diverse
assortment of medical conditions. These include sei-
zure disorders, psychotic symptoms, anxiety, depres-
sion, inflammation, cancer, cardiovascular diseases,
neurodegeneration, symptoms of multiple sclerosis,
and chronic pain, either used alone or when coadmi-
nistered with THC.
5–20
In October of 2017, a New Drug Application was sub-
mitted to the U.S. Food and Drug Administration (FDA)
to seek approval of CBD isolated from marijuana for the
treatment of two pediatric seizure disorders. Approval
was granted in June, 2018, making Epidiolex (cannabi-
diol) the first plant-derived Cannabis compound
approved as a drug by the FDA. Availability of Epidiolex
is pending Drug Enforcement Administration (DEA)
1
The Center for Medical Cannabis Education, Del Mar, California.
2
Helfgott Research Institute, National University of Natural Medicine (NUNM), Portland, Oregon.
3
Donald P. Shiley BioScience Center, San Diego State University, San Diego, California.
*Address correspondence to: Jamie Corroon, ND, MPH, The Center for Medical Cannabis Education, 1155 Camino Del Mar, #187, Del Mar, CA 92014, E-mail: jamie@corroon.com
ªJamie Corroon and Joy A. Phillips 2018; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative
Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided
the original work is properly cited.
Cannabis and Cannabinoid Research
Volume 3.1, 2018
DOI: 10.1089/can.2018.0006
Cannabis and
Cannabinoid Research
152
rescheduling of cannabidiol, which is expected to occur
within 90 days.
21–23
Sativex (nabiximols), a combination
drug with equal parts CBD and THC extracted from
marijuana, is currently approved to treat spasticity due
to multiple sclerosis in >30 countries worldwide but is
not approved in the United States.
17,21
The worldwide regulatory status of CBD is complex
and constantly changing.
5
While CBD is legal in many
countries as a component of prescription Sativex
(nabiximols), it may be simultaneously illegal as a com-
ponent of a nonapproved Cannabis extract containing
>0.2% (particularly in European countries) or 0.3%
THC. In Europe, individual European Union Member
States currently determine the legality of CBD within
their borders. Most allow prescription CBD products,
as do Australia and New Zealand.
5,24
Canada became
the second nation in the world to legalize Cannabis
for recreational use in June 2018.
25
The World Health
Organization’s Expert Committee on Drug Dependence
recommended that CBD should not be controlled by
Schedule I of the 1961 UN Single Convention on Nar-
cotic Drugs.
5
Their comprehensive report is expected
this year.
In the United States, until such time as it is resched-
uled, CBD from marijuana is deemed by the DEA to
fall within the purview of the ‘‘marihuana extract
rule’’ (Rule). A dispute over the scope of the Rule was
litigated in federal court. The Court found that the
Rule applies to extracts of marijuana but that the indus-
trial hemp provisions of the 2014 Farm Act (i.e., ‘‘The
2014 Farm Bill’’) preempt the Controlled Substances
Act (CSA), which the DEA enforces.
26
Thus, hemp cul-
tivated in compliance with the Farm Bill is not a con-
trolled substance. The Court did not address the issue
of CBD directly, however, and left open the issue of
the legal status of CBD derived from industrial hemp,
from imported ‘‘nonpsychoactive hemp’’ or from
parts of the Cannabis sativa plant excluded from the
legal definition of marijuana in the Controlled Substan-
ces Act of 1970.
27–35
Despite conflicting legal interpre-
tations, and DEA prohibition, hemp-derived CBD
products can currently be purchased as dietary supple-
ments both online and over the counter throughout
most of the country. To complicate matters further,
the FDA does not recognize CBD as a dietary supple-
ment ingredient because of its status as an Investiga-
tional New Drug.
36
This regulatory confusion has not deterred consum-
ers from exploring the purported benefits of CBD. Retail
sales of hemp-derived CBD products in the United
States reached $170 million in 2016, and are projected
to grow at a 55% compound annual growth rate over
the next 5 years to reach >$1 billion. These estimates
do not include marijuana-derived CBD.
37
Although
Cannabis users have been extensively studied data
characterizing the individual use of CBD are scarce.
The goal of this study was to collect survey data to elu-
cidate how, and why, individuals are using CBD.
Methods
Survey
The study protocol was submitted electronically to the
Institutional Review Board (IRB) of San Diego State
University. Given the voluntary nature of the survey,
and the lack of identifying information, the electronic
approval process determined that no IRB approval
was necessary.
We developed a novel questionnaire to assess broad
characteristics of self-described CBD users and under-
lying reasons for, and methods of, CBD use. The survey
consisted of structured questions answered by either
yes/no or multiple-choice responses. Questions focused
on several key domains: sociodemographics; reasons
for use; duration and frequency of use; method of ad-
ministration; perceived clinical efficacy; and adverse ef-
fects. Study data were collected and managed using
Qualtrics
Survey Software, a secure tool allowing par-
ticipants to directly enter responses anonymously.
Subjects were a self-selected convenience sample
who accessed the online survey from October 25,
2017 to January 25, 2018. Recruitment strategies in-
cluded promotion on survey-specific Web pages on
Facebook, LinkedIn, and ResearchGate. CBD product
manufacturers and herbal vaporizer manufacturers
assisted in recruitment by promoting links to the sur-
vey on their Facebook pages and/or via email to their
customers. The only inclusion criterion was current
or prior use of CBD. Respondents could skip any ques-
tion(s) they did not wish to answer.
Data analyses
Descriptive statistics including simple proportions
were used to describe demographics, usage characteris-
tics, medical conditions, perceived efficacy, side effects,
and other CBD use preferences. Data analyses were
conducted using SAS University Edition (SAS 9.4;
SAS Institute Inc., Cary, NC). Univariate and bivariate
comparisons were conducted using PROC FREQ and
chi-square tests. Odds ratios (ORs) were used to esti-
mate strength of association using PROC LOGISTIC.
Corroon and Phillips; Cannabis and Cannabinoid Research 2018, 3.1
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153
Statistical significance was assessed using a=0.05. Fig-
ures were produced using DeltaGraph version 4.5 for
Mac.
Results
Demographics
A total of 2490 responses were collected. Eighty-one re-
spondents were excluded from the analysis for failure to
answer the first question regarding stated use of CBD,
leaving 2409 respondents included in the final study
population. The sample was balanced in terms of gender
(female: 50.87%; male: 47.40%) with most respondents
reporting ages between 55 and 74 years (39.97%).
Most were either graduates of, or currently enrolled in,
college or a postgraduate program (71.22%). The vast
majority resided in the United States (91.23%). Respond-
ents from all 50 U.S. states were represented in the sur-
vey with the majority residing in California (n=412,
21.90%; Table 1). In addition, there were survey respon-
dents from 23 other countries. Regular Cannabis use was
reported by 55.17% of respondents.
Stated use: medical versus general health
and well-being
More than 60% (61.56%) reported using CBD to treat a
medical condition(s) (Table 1). The odds of using CBD
to treat a medical condition were 1.65 (95% confidence
interval [CI], 1.39–1.97) times greater among women
than among men, higher with age, and roughly equal
among residents and nonresidents of the United States
(OR, 1.06; 95% CI, 0.9–2.5; Table 2). Respondents <18
years of age were subsequently assessed as an indepen-
dent category despite the small number of observations
(n=25) and wide CI (OR, 18.72; 95% CI, 4.20–83.39,
compared with those between 18 and 24 years of age.
Data not included in Table 2). This additional analysis
was based on the established use of CBD to treat pedi-
atric seizure disorders
6,7,16
and the percentage of re-
spondents in that age category reporting using CBD
to treat a medical condition (n=23; 92%).
The odds of using CBD to treat a medical condition
were 1.44 (95% CI, 1.16–1.79) times greater among
nonregular users of Cannabis when compared with
regular users.
Medical conditions
There were 1483 respondents who reported using CBD
to treat at least one medical condition. A minimum of
3963 medical conditions were reported. This represents
an average of more than two and a half (mean: 2.67)
different medical conditions per respondent.
In order of frequency, the top three medical condi-
tions reported were chronic pain, arthritis/joint pain,
and anxiety (Fig. 1).
Respondents selected ‘‘Other’’ 362 times. The most
common ‘‘Other’’ conditions reported were neuropathy
(n=48), autoimmune conditions (n=38), and fibro-
myalgia (n=37).
Methods of administration
A total of 4135 methods of administration were reported
by 2200 respondents. This represents an average of al-
most two (mean: 1.88) different methods of administra-
tion per respondent. Overall, the most common method
reported was the administration of CBD in a sublingual
Table 1. Sociodemographic and Other Characteristics
of Survey Respondents (n=2409)
n(%)
Gender
Male 1013 (47.40)
Female 1087 (50.87)
Decline to state 37 (1.73)
Missing 272
Age (years)
£24 138 (6.33)
25–34 292 (13.40)
35–44 400 (18.36)
45–54 404 (18.54)
55–64 532 (24.41)
65–74 339 (15.56)
75 74 (3.40)
Missing 230
Education
Primary/middle school 22 (1.01)
High school/GED 503 (23.13)
College 1138 (52.32)
Postgraduate 411 (18.90)
Other 101 (4.64)
Missing 234
Geography
United States 1987 (91.23)
Canada/Mexico 103 (4.73)
Other 88 (4.04)
Missing 231
Geography—U.S. states (top 5)
California 412 (21.90)
Texas 93 (4.94)
Oregon 83 (4.41)
Florida 79 (4.20)
Colorado 76 (4.04)
Missing 528
Cannabis use
Regular 1189 (55.17)
Nonregular 966 (44.83)
Missing 254
CBD use
General health and well-being 926 (38.44)
Medical condition 1483 (61.56)
Missing 0
CBD, cannabidiol; GED, General Educational Development.
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Table 2. Odds of Using Cannabidiol for a Medical Condition by Sociodemographic and Other Characteristics (n=2409)
General health and well-being, (n=926) Medical condition, (n=1483)
OR (95% CI)n(%) n(%)
Gender***
Male 454 (44.82) 559 (55.18) 1.00 (reference)
Female 358 (32.93) 729 (67.07) 1.65 (1.39–1.97)
Decline to state 12 (32.43) 25 (67.57) 1.69 (0.84–3.41)
Missing 102 170
Age (years)***
£24 72 (52.17) 66 (47.83) 1.00 (reference)
25–34 153 (52.40) 139 (47.60) 0.99 (0.66–1.49)
35–44 170 (42.50) 230 (57.50) 1.48 (1.00–2.18)
45–54 150 (37.13) 254 (62.87) 1.85 (1.30–2.73)
55–64 180 (33.83) 352 (66.17) 2.13 (1.50–3.12)
65–74 98 (28.91) 241 (71.09) 2.68 (1.80–4.04)
75 19 (25.68) 55 (74.32) 3.16 (1.70–5.86)
Missing 84 146
Education***
College 478 (42.00) 660 (58.00) 1.00 (reference)
Primary/middle school 1 (4.55) 21 (95.45) 15.18 (2.04–113.09)
High school/GED 172 (34.19) 331 (65.81) 1.39 (1.12–1.73)
Postgraduate 153 (37.23) 258 (62.77) 1.22 (0.97–1.54)
Other 34 (33.66) 67 (66.34) 1.43 (0.93–2.19)
Missing 88 146
Geography
United States 763 (38.40) 1224 (61.60) 1.00 (reference)
Canada/Mexico/other 76 (39.79) 115 (60.21) 1.06 (0.78–1.44)
Missing 87 144
Cannabis use***
Regular 509 (42.81) 680 (57.19) 1.00 (reference)
Nonregular 320 (33.13) 646 (66.87) 1.44 (1.16–1.79)
Missing 97 157
***p<0.001.
CI, confidence interval; OR, odds ratio.
FIG. 1. Number of medical conditions for which respondents reported using CBD, by medical condition
(n=3963). CBD, cannabidiol; COPD, chronic obstructive pulmonary disease; PTSD, post-traumatic stress
disorder.
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155
form (Fig. 2). This includes liquids administered as
sprays, drops, and tinctures. The least common method
was topical use.
More than half (51.36%) of those reporting a method
of administration reported using only one method (n=
1130; missing =209; not including ‘‘Other,’n=31). On
average, respondents who reported using one method
of administration were 1.6 times more likely to use
CBD for a medical condition than for general health
and well-being (medical condition, n=691; general
health and well-being, n=439). Medical users reporting
one method of administration were 2.4 times more likely
to use a topical form, 2.0 times more likely to use an ed-
ible form of CBD, and 1.8 times more likely to use CBD
in a sublingual or pill or capsule form than general health
and well-being users reporting one method.
Learning about CBD, frequency and duration of use
Overall, 75.85% of respondents reported learning about
CBD from internet research, family members, or
friends. Of the remaining respondents, medical users
were more likely to learn about CBD from a Medical
Doctor or Naturopathic Doctor and to use it more
frequently than those using it for general health and
well-being. The odds of using CBD to treat a medical
condition were 1.79 (95% CI, 1.46–2.19) times greater
among respondents using it more than once per day
compared with those using it daily (Table 3). Duration
of use was more variable, but the odds of using CBD to
treat a medical condition were greater among those
using it for <5 years (Table 3).
Treatment efficacy
Only respondents who reported using CBD to treat
a medical condition were asked about its efficacy
(n=1483). Almost 36% (35.80%) of respondents
reported that CBD treats their medical condition(s)
‘‘very well by itself,’’ while only 4.30% reported ‘‘not
very well’’ (Table 4). Respondents most frequently
reported feeling that CBD treated their medical con-
dition(s) ‘‘very well by itself’’ or ‘‘moderately well
by itself’’ for the following three conditions: chronic
pain, arthritis/joint pain, and anxiety (Fig. 3).
The odds of regular Cannabis useweretwotothree
times greater among those who reported feeling that
CBD treated their medical condition ‘‘very well by itself’
(OR, 2.32; 95% CI, 1.29–4.18) or ‘‘moderately well by
itself’’ (OR, 2.92; 95% CI, 1.61–5.29; see Table 4).
Side effects
A minimum of 1314 side effects were reported across
2409 respondents (missing, n=1095). Seven hundred
eighty-five (59.74%) of these effects were categorized
as adverse (Table 5). On average, this represents at
least one reported adverse effect in approximately
one out of every three (3.07) users of CBD.
The top five most frequently reported adverse effects
were dry mouth (n=268, 11.12% of all CBD users), eu-
phoria (n=155, 6.43%), hunger (n=153, 6.35%), red
eyes (n=66, 2.74%), and sedation/fatigue (n=43,
1.78%). Just under 30% (28.46%) of medical users
reported an adverse effect when compared with
34.56% of general health and well-being users.
Discussion
To our knowledge, this is the first published survey
(aside from industry reports) that specifically analyzes
CBD users, as opposed to overall Cannabis or medical
Cannabis users. The results of this study suggest that
CBD is used more frequently as a specific therapy for
medical conditions than for general health and well-
being. This stands in contrast to the majority of mari-
juana users, who largely use THC-dominant Cannabis
for recreational or nonmedical reasons.
38
The most common medical condition for which
CBD was reportedly used was pain. In preclinical
studies, CBD-based analgesia is associated with po-
tent immune-modulatory, anti-inflammatory, and
FIG. 2. Number and percentage of methods of
administering CBD (n=4135).
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156
antioxidant activity.
39–47
CBDactsasanagonistfora
wide variety of cell-surface receptors including aden-
osine A2
A
,5-HT
1A
,TRPV1,a7nAch, a3glycinere-
ceptors, and the peroxisome proliferator-activated
receptor gamma (PPAR-c) nuclear receptor. These
receptors are all associated with anti-inflammatory
activity.
48–58
Consistent with the efficacy reported
by survey respondents, CBD has been shown to re-
duce inflammatory cytokines in murine models of in-
flammatory disease and chronic and acute pain.
59
The endocannabinoid system may also play a role in
CBD-mediated analgesia. CBD inhibits enzymes (i.e.,
fatty acid amide hydrolase and monoacylglycerol lipase)
that degrade endocannabinoids. This inhibition is associ-
ated with increased endocannabinoid levels, analgesia,
and opioid-sparing effects in preclinical models of pain.
60
Anxiety and depression were also commonly reported
reasons for CBD use in this survey. CBD has long been
proposed to inhibit THC-associated anxiety by antago-
nizing cannabinoid receptor activation by THC.
61–63
CBD may also reduce anxiety via the serotonin 5-
HT
1A
and/or GABA
A
receptors.
14,64
These receptor
pathways are being explored in hopes of novel thera-
peutic strategies for phobias, post-traumatic stress dis-
order, and drug abuse.
65,66
Themajorityofsurveyrespondentslearnedabout
CBD from internet research, family members, or
friends. This was the case for both medical and gen-
eral health and well-being users. Over 74% of respon-
dents reported using CBD daily or more than daily.
Sublingual delivery was the most common route of
administration in both groups. The frequency of
use of sublingual preparations found in this study
contradicts a recent industry-funded CBD survey
where respondents reported more frequent vaping,
smoking, and topical use.
67
This industry survey
was collected from customers of an online medical
marijuana recommendation service. Presumably,
these respondents were seeking marijuana-derived
products, so the frequency of inhalation as a method
Table 3. Odds of Using Cannabidiol for a Medical Condition, by Cannabidiol Usage Characteristics (n=2409)
General health and well-being, (n=926) Medical condition, (n=1483)
OR (95% CI)n(%) n(%)
Learned about CBD**
Family member/friend 320 (41.24) 456 (58.76) 1.00 (reference)
Internet research 337 (38.04) 549 (61.96) 1.14 (0.94–1.39)
Physician/naturopathic doctor 58 (27.36) 154 (72.64) 1.86 (1.33–2.60)
Other (please specify) 131 (41.32) 186 (58.68) 1.00 (0.76–1.30)
Missing 80 138
Frequency of use***
Daily 418 (39.70) 635 (60.30) 1.00 (reference)
<Once per day 227 (56.47) 175 (43.53) 0.51 (0.40–0.64)
>Once per day 196 (26.92) 532 (73.08) 1.79 (1.46–2.19)
Missing 85 141
Duration of use (years)*
>5 134 (53.17) 118 (46.83) 1.00 (reference)
2–5 151 (35.61) 273 (64.39) 2.05 (1.50–2.82)
1–2 202 (42.98) 268 (57.02) 1.51 (1.11–2.05)
<1 364 (34.57) 689 (65.43) 2.15 (1.63–2.84)
Missing 75 135
*p<0.05, **p<0.01, ***p<0.001.
Table 4. Number and Percentage of Respondents Using Cannabidiol for a Medical Condition, by Treatment Efficacy
and Regular Cannabis Use
How well do you feel CBD treats
your medical condition(s)? (n=1483)
Regular cannabis use (n=674) Nonregular cannabis use (n=628)
OR (95% CI)n(%) n(%)
Not very well 57 (4.30) 18 (31.58) 39 (68.42) 1.00 (reference)
Well in combination with
conventional medicine*
404 (30.44) 195 (49.24) 201 (50.76) 2.11 (1.170–3.82)
Moderately well by itself*** 391 (29.46) 221 (57.40) 164 (42.60) 2.92 (1.61–5.29)
Very well by itself 475 (35.80) 240 (51.72) 224 (48.28) 2.32 (1.29–4.18)
Missing** 156 0 0 0
*p<0.05, **p<0.01, ***p<0.001.
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of administration is consistent with marijuana users
overall.
68
Our finding may be in part due to the
fact that hemp-derived CBD products are largely dis-
tributed online and in health-food stores and widely
offered as oral preparations.
The percentage of respondents (55.17%) who
reported regular Cannabis use is markedly higher
than national estimates. In 2015, an estimated 8.3%
(*22.2 million people) of individuals aged 12 years
or older had used marijuana in the past month.
69
The
reason for the higher rate of Cannabis use among survey
respondents is not clear, although one possibility is that
Cannabis users would be more likely to have heard of
CBD. However, CBD use by a relatively high percentage
(44.83%) of nonregular Cannabis users suggests that in-
dividuals are not using CBD as a perceived legal route to
THC consumption.
Approximately half of all respondents reported
using CBD for <1 year. Just over 10% reported using
CBD for >5 years. Nonserious adverse effects were rel-
atively common among respondents and higher among
those using CBD for general health and well-being, de-
spite the fact that this group reported less frequent use
than medical users. While dry mouth, sedation/fatigue,
decreased appetite, and diarrhea have previously been
reported following CBD use,
6,7
other studies have dem-
onstrated no adverse effects.
10,70–72
This dichotomy
may be related to dose, interactions with prescription
medications, or both. More broadly, adverse effects
may also be related to the method of administration
and/or the use of purified, high-dose CBD as opposed
to CBD in a whole plant extract. These questions and
more reinforce the need for more research on unan-
ticipated consequences of CBD use, particularly the
FIG. 3. Number of medical conditions for which respondents report CBD treating ‘‘Very Well by Itself’’ or
‘‘Moderately Well by Itself,’’ by medical condition (n=2557).
Table 5. Most Common Adverse Effects Reported by Survey Respondents (n=742)
Adverse effect
Medical condition (n=1483) General health and well-being (n=926) Total (n=2409)
n (%) n (%) n (%)
Dry mouth 174 (11.73%) 94 (10.15%) 268 (11.12%)
Euphoria 59 (3.98%) 96 (10.37%) 155 (6.43%)
Hunger 80 (5.39%) 73 (7.88%) 153 (6.35%)
Other 46 (3.10%) 11 (1.19%) 57 (2.37%)
Red eyes 34 (2.29%) 32 (3.46%) 66 (2.74%)
Sleepy/groggy 29 (1.96%) 14 (1.51%) 43 (1.78%)
Total adverse effects 422 (28.46%) 320 (34.56%) 742 (30.80%)
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impact of long-term usage.
4,5
Many of the adverse ef-
fects reported in this study (i.e., euphoria, hunger,
and red eyes) are commonly associated with THC
use.
73
These analyses did not attempt to discriminate
between hemp-derived CBD and marijuana-derived
CBD products, which may have differing chemical con-
stituents (including THC content) and therefore differ-
ent effects. Further, no discrimination could be made
between isolated CBD and CBD used as a constituent
of a whole plant extract.
Industry-originated studies have found that users are
confused about the source of their CBD and the con-
centration of CBD and other ingredients.
67–74
It is
worth noting that independent research has confirmed
that the CBD content in almost 70% of CBD-labeled
products available online may be mislabeled. In one
study, 43% of products were underlabeled and 26%
were overlabeled for actual CBD content. More than
20% contained detectable levels of THC.
75
Since CBD-
containing products are largely unregulated there is no ob-
vious way for users to know the quantity of CBD, or other
constituents, which may be present in the products they
use. Given this uncertainty, it is possible that some of
the reported efficacy and the adverse effects may be in
part due to the inclusion of other compounds in the
CBD preparation, including THC.
Strengths and limitations
This study has several strengths, including the size,
geographic representation of the sample, wide age
range of the respondents, and a focus on specific
usage characteristics. In part, this was the result of uti-
lizing multiple recruitment methodologies.
In terms of limitations, the study population was a
self-selected convenience sample, and as such, may
not be representative of the general population or the
overall population of CBD users. Individuals with
favorable opinions of or experiences with CBD or
Cannabis are more likely to have responded to the
questionnaire than those with negative opinions and
experiences. In addition, ‘‘regular cannabis use’’ was
not defined in the survey and ‘‘marijuana’’ was not dis-
tinguished from ‘‘Cannabis.’’ Since the survey was pri-
marily circulated via the internet, CBD users with
limited social media connectivity would be underrepre-
sented. Finally, no mechanism for identifying repeat re-
spondents was incorporated into the survey. Although
results were examined manually, it is possible that re-
peat respondents may have distorted the results (i.e.,
Ballot stuffing).
Conclusion
The use of CBD among individuals for both specific
health conditions and general health and well-being is
widespread. The results of this study demonstrate that
individuals are learning about CBD from the internet,
friends, or family members, rather than from healthcare
professionals. CBD is being used as a specific therapy for
a number of diverse medical conditions—particularly
pain and inflammatory disorders, in addition to anxiety,
depression, and sleep disorders. A large percentage of
respondents indicate that CBD treats their condition(s)
effectively in the absence of conventional medicine and
with nonserious adverse effects. These data provide a
compelling rationale for further research to better un-
derstand the therapeutic potential of CBD in treating
chronic pain, anxiety, depression, sleep disorders, and
other medical conditions.
Acknowledgments
The authors thank Gina Spidel for help with survey de-
sign, proofreading, and assistance with the SDSU Elec-
tronic Internal Review Board; Edgar Herrera for setting
up the survey Facebook page; Belle Della Cruz for help
with survey wording; and Rod Kight, Esq., for assis-
tance in clarifying the regulatory status of CBD in the
United States.
Author Disclosure Statement
J.C. is the Medical Director at The Center for Medical
Cannabis Education, a for-profit clinical, research and
consulting entity.
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Cite this article as: Corroon J, Phillips JA (2018) A cross-sectional
study of cannabidiol users, Cannabis and Cannabinoid Research 3:1,
152–161, DOI: 10.1089/can.2018.0006.
Abbreviations Used
CBD ¼cannabidiol
CI ¼confidence interval
COPD ¼chronic obstructive pulmonary disease
FDA ¼Food and Drug Administration
GED ¼General Educational Development
IRB ¼institutional review board
OR ¼odds ratio
PTSD ¼post-traumatic stress disorder
THC ¼tetrahydrocannabinol
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... The safety profile of CBD (e.g., potential adverse events and drug-drug interactions) is not sufficiently understood (Brown & Winterstein, 2019;Sholler et al., 2020). Evidence from international online surveys (Corroon & Phillips, 2018;Fedorova et al., 2021), studies analyzing posts of CBD users on social media (Leas et al., 2020), and crowd-funding platforms (Zenone et al., 2020) suggest that CBD is used to self-medicate numerous conditions for which evidence-based therapies are available, including chronic pain, depression, asthma, and cancer. The substitution of evidence-based therapies with CBD could result in delayed treatment with effective therapies and unnecessarily prolonged illness (Leas et al., 2020). ...
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... A large cross-sectional survey of a predominantly North American convenience sample (n = 2490) found over half the population using CBD medicinally, with cancer as a top 10 indication. 1 Little is known about oncologists' clinical opinions of CBD use or how and why cancer patients use CBD medicinally. We conducted secondary analyses of quantitative and qualitative data sets to describe perceptions among both groups regarding the role of CBD in oncological care. ...
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Design of Experiments (DoE) is a well-established tool used for analytical methods robustness studies, because of its ability to assess the effect of a great number of factors in a minimal number of experiments. However, when assessing the robustness of an analytical method the analysis of the individual effect of each factor is not sufficient on its own. Some factors may not influence the robustness of the method, but their effect combined with the effects of other factors may have a significant contribution on the robustness of the method, which is not given by conventional analysis of DoE results. The aim of this work is to propose, in addition to the analysis of the individual effects of the factors, to estimate the joint effect of the factors by means of the matrix experimental results prediction interval. This prediction interval is the interval in which, with a given probability, should fall the next results, therefore it is an interesting tool to estimate the variation limits of the method results during routine use. We also propose the use of two other prediction intervals which can help to analyze the DoE results and give a conclusion on the method robustness. The first one is based on the DoE experimental error information, and it gives an estimation of the experimental error component impact on the factors joint effect. The second one is based on the factors non-significance limits, and it provides the information regarding the factors impact on the responses in the case where the conditions are, by definition, robust. We applied these proposals to the robustness study of a UHPLC method for the separation of phytocannabinoids and we could demonstrate that, in addition to the calculated effects values and robustness information, the use of the prediction intervals information provided additional information that allowed a better interpretation of the method performance parameters.
Article
Background: Cannabidiol (CBD) has gained popularity in the United States, particularly among certain populations, including young adults. Thus, we examined (1) CBD product knowledge, perceptions, use, and use intentions among young adults and (2) correlates of use and use intentions. Methods: We analyzed data from a Fall 2020 survey regarding tobacco and other substance use among 2464 young adults in 6 U.S. cities (Mage=24.67; 57.4% female; 28.7% racial/ethnic minority). We used multinomial regression to identify correlates of use status (i.e., former [ever but no past 6 months] use vs. current [past 6 months] and never use, respectively), and linear regression to examine use intentions among never users. Results: Around 51.4% reported ever use, and 32.0% reported current use. On average, participants perceived CBD as safe and effective for addressing pain, anxiety, and sleep (also prominent use motives: ∼40% to 60%, respectively). Use intentions were relatively high, particularly for edibles and topicals (also the most common use modes). Roughly one-fourth mistakenly believed that CBD products were required to be approved by U.S. Food and Drug Administration (24.9%), tested/proven safe (28.8%), and proven effective to be marketed for pain, anxiety, sleep, and so on. (27.2%). Compared to former users, never users perceived greater CBD-related risk (p<0.001), less social acceptability (p<0.001), and greater difficulty accessing CBD (p=0.004); current users perceived more health benefits (p<0.001). Among never users, greater use intentions were associated with greater perceived social acceptability (p<0.001), health benefits (p<0.001), and difficulty accessing CBD (p=0.005). Conclusions: Given misperceptions about CBD, surveillance of young adults' knowledge, perceptions, and use of CBD is critical as its market expands.
Article
Background Regulation has not kept pace with the growth of the hemp-derived CBD market. We have evaluated the risk of Δ⁹-tetrahydrocannabinol (Δ⁹-THC) contamination in 80 unregulated products with comparison to a regulated control, Epidiolex®. Methods Local and national brands of hemp-derived oil products were purchased online and from local retailers in central Kentucky (which carry both national and local brands). These were extracted by solvent extraction and quantified by liquid-chromatography tandem mass-spectrometry (LC-MS/MS) using a validated method. Results Of the 80 unregulated products and Epidiolex®, Δ⁹-THC was detected above the limit of quantification (LOQ = 0.005 mg/mL) of the assay in 52 samples, ranging from 0.008 mg/mL to 2.071 mg/mL. Twenty-one of the products tested were labelled as “THC-Free”, and 5 of these products contained detectable levels of Δ⁹-THC ranging from 0.015 mg/mL to 0.656 mg/mL. Conclusions Consumers are taking hemp-derived CBD products without understanding the risks of unintentional consumption of Δ⁹-THC. This accidental use of Δ⁹-THC could have adverse effects on health and safety as well as potential legal consequences (e.g., child custody, impaired driving), as Δ⁹-THC drug test findings could impact employment, military, and sport eligibility status.
Article
Objectives Federal hemp legalization and ongoing shifts in US marijuana laws have led to increased population-wide use of cannabidiol (CBD) supplements, often without the knowledge of primary healthcare providers (PCPs). Given the potential risks related to CBD use, especially in vulnerable subgroups, improved communication is warranted. This study aimed to examine PCP attitudes, experiences, and practice behaviors related to CBD and provider-reported barriers to communication with patients about CBD use. Methods Fourteen PCPs were recruited and participated in semi-structured interviews. Transcripts were digitally analyzed using inductive thematic analysis. Results Analyses identified that most PCPs had neutral views about CBD use by their patients. The study found that discussions about CBD use were initiated by patients. Most PCPs cited lack of time, discomfort, low-quality evidence, and low prioritization as reasons for not discussing CBD with patients. Conclusion PCPs rarely screen for or discuss CBD use with their patients and most of them had neutral views about CBD use by their patients. A number of barriers exist to open dialogue about CBD. Innovation Our study is the first in-depth report on PCP attitudes, experiences, and practice behaviors related to CBD. The findings of our study have the potential to significantly impact future PCP practice behaviors. These results can inform healthcare system policies around screening for CBD use and PCP communication training. In doing so, these efforts may mitigate risk and optimize benefits related to the expanding CBD market.
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There is growing consumer demand for cannabidiol (CBD), a constituent of the cannabis plant, due to its purported medicinal benefits for myriad health conditions.¹ Viscous plant-derived extracts, suspended in oil, alcohol (tincture), or vaporization liquid, represent most of the retail market for CBD. Discrepancies between federal and state cannabis laws have resulted in inadequate regulation and oversight, leading to inaccurate labeling of some products.² To maximize sampling and ensure representativeness of available products, we examined the label accuracy of CBD products sold online, including identification of present but unlabeled cannabinoids.
Article
In 1937, the United States of America criminalized the use of cannabis and as a result its use decreased rapidly. In recent decades, there is a growing interest in the wide range of medical uses of cannabis and its constituents; however, the laws and regulations are substantially different between countries. Laws differentiate between raw herbal cannabis, cannabis extracts, and cannabinoid-based medicines. Both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) do not approve the use of herbal cannabis or its extracts. The FDA approved several cannabinoid-based medicines, so did 23 European countries and Canada. However, only four of the reviewed countries have fully authorized the medical use of herbal cannabis - Canada, Germany, Israel and the Netherlands, together with more than 50% of the states in the United States. Most of the regulators allow the physicians to decide what specific indications they will prescribe cannabis for, but some regulators dictate only specific indications. The aim of this article is to review the current (as of November 2017) regulations of medical cannabis use in Europe and North America.
Article
Objective: Research in both animals and humans indicates that cannabidiol (CBD) has antipsychotic properties. The authors assessed the safety and effectiveness of CBD in patients with schizophrenia. Method: In an exploratory double-blind parallel-group trial, patients with schizophrenia were randomized in a 1:1 ratio to receive CBD (1000 mg/day; N=43) or placebo (N=45) alongside their existing antipsychotic medication. Participants were assessed before and after treatment using the Positive and Negative Syndrome Scale (PANSS), the Brief Assessment of Cognition in Schizophrenia (BACS), the Global Assessment of Functioning scale (GAF), and the improvement and severity scales of the Clinical Global Impressions Scale (CGI-I and CGI-S). Results: After 6 weeks of treatment, compared with the placebo group, the CBD group had lower levels of positive psychotic symptoms (PANSS: treatment difference=-1.4, 95% CI=-2.5, -0.2) and were more likely to have been rated as improved (CGI-I: treatment difference=-0.5, 95% CI=-0.8, -0.1) and as not severely unwell (CGI-S: treatment difference=-0.3, 95% CI=-0.5, 0.0) by the treating clinician. Patients who received CBD also showed greater improvements that fell short of statistical significance in cognitive performance (BACS: treatment difference=1.31, 95% CI=-0.10, 2.72) and in overall functioning (GAF: treatment difference=3.0, 95% CI=-0.4, 6.4). CBD was well tolerated, and rates of adverse events were similar between the CBD and placebo groups. Conclusions: These findings suggest that CBD has beneficial effects in patients with schizophrenia. As CBD's effects do not appear to depend on dopamine receptor antagonism, this agent may represent a new class of treatment for the disorder.
Article
Objectives: Spasticity remains highly prevalent in patients with spinal cord injury and multiple sclerosis. To summarize the effects of cannabinoids compared with usual care, placebo for spasticity due to multiple sclerosis (MS) or paraplegia. Methods: Searches of MEDLINE, EMBASE, CENTRAL and LILACS to March 2017 were performed to identify randomized controlled trials. The primary outcomes were spasticity and spasm frequency. The criteria were any patient with MS and spasticity affecting upper or lower limbs or both, and that had a confirmed diagnosis of MS based on validated criteria, or however defined by the authors of the included studies. Results: 16 trials including 2597 patients were eligible. Moderate-certainty evidence suggested a non-statistically significant decrease in spasticity (standardized mean difference (SMD) 0.36 [confidential interval (CI) 95% -0.17 to 0.88; p=0.18; I2=88%]), and spasm frequency (SMD 0.04 [CI 95% -0.15 to 0.22]). There was an increase in adverse events such as dizziness (risk ratio (RR) 3.45 [CI 95% 2.71-4.4; p=0.20; I2=23%]), somnolence (RR 2.9 [CI 95% 1.98-4.23; p=0.77; I2=0%]), and nausea (RR 2.25 [CI 95% 1.62-3.13; p=0.83; I2=0%]). Conclusions: There is moderate certainty evidence regarding the impact of cannabinoids in spasticity (average 0.36 more spasticity; 0.17 fewer to 0.88 more) due to multiple sclerosis or paraplegia, and in adverse events such as dizziness (419 more dizziness/1000 over 19 weeks), somnolence (127 more somnolence/1000 over 19 weeks), and nausea (125 more somnolence/1000 over 19 weeks).
Article
The Drug Enforcement Administration is creating a new Administration Controlled Substances Code Number for "Marihuana Extract." This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions. Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols. The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: "Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant." Extracts of marihuana will continue to be treated as Schedule I controlled substances.
Article
Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment of these medical conditions, CBD has a better side effect profile. This could improve patients' compliance and adherence to treatment. CBD is often used as adjunct therapy. Therefore, more clinical research is warranted on CBD action on hepatic enzymes, drug transporters, and interactions with other drugs and to see if this mainly leads to positive or negative effects, for example, reducing the needed clobazam doses in epilepsy and therefore clobazam's side effects. Conclusion: This review also illustrates that some important toxicological parameters are yet to be studied, for example, if CBD has an effect on hormones. Additionally, more clinical trials with a greater number of participants and longer chronic CBD administration are still lacking.
Article
Background: Cannabidiol (CBD) is a nonpsychoactive phytocannabinoid used in multiple sclerosis and intractable epilepsies. Preclinical studies show CBD has numerous cardiovascular benefits, including a reduced blood pressure (BP) response to stress. The aim of this study was to investigate if CBD reduces BP in humans. Methods: Nine healthy male volunteers were given 600 mg of CBD or placebo in a randomized, placebo-controlled, double-blind, crossover study. Cardiovascular parameters were monitored using a finometer and laser Doppler. Results: CBD reduced resting systolic BP (-6 mmHg; P < 0.05) and stroke volume (-8 ml; P < 0.05), with increased heart rate (HR) and maintained cardiac output. Subjects who had taken CBD had lower BP (-5 mmHg; P < 0.05, especially before and after stress), increased HR (+10 bpm; P < 0.01), decreased stroke volume (-13 ml; P < 0.01), and a blunted forearm skin blood flow response to isometric exercise. In response to cold stress, subjects who had taken CBD had blunted BP (-6 mmHg; P < 0.01) and increased HR (+7 bpm; P < 0.05), with lower total peripheral resistance. Conclusions: This data shows that acute administration of CBD reduces resting BP and the BP increase to stress in humans, associated with increased HR. These hemodynamic changes should be considered for people taking CBD. Further research is required to establish whether CBD has a role in the treatment of cardiovascular disorders.
Article
Background The Dravet syndrome is a complex childhood epilepsy disorder that is associated with drug-resistant seizures and a high mortality rate. We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome. Methods In this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg per kilogram of body weight per day or placebo, in addition to standard antiepileptic treatment. The primary end point was the change in convulsive-seizure frequency over a 14-week treatment period, as compared with a 4-week baseline period. Results The median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with cannabidiol, as compared with a decrease from 14.9 to 14.1 with placebo (adjusted median difference between the cannabidiol group and the placebo group in change in seizure frequency, −22.8 percentage points; 95% confidence interval [CI], −41.1 to −5.4; P=0.01). The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with cannabidiol and 27% with placebo (odds ratio, 2.00; 95% CI, 0.93 to 4.30; P=0.08). The patient’s overall condition improved by at least one category on the seven-category Caregiver Global Impression of Change scale in 62% of the cannabidiol group as compared with 34% of the placebo group (P=0.02). The frequency of total seizures of all types was significantly reduced with cannabidiol (P=0.03), but there was no significant reduction in nonconvulsive seizures. The percentage of patients who became seizure-free was 5% with cannabidiol and 0% with placebo (P=0.08). Adverse events that occurred more frequently in the cannabidiol group than in the placebo group included diarrhea, vomiting, fatigue, pyrexia, somnolence, and abnormal results on liver-function tests. There were more withdrawals from the trial in the cannabidiol group. Conclusions Among patients with the Dravet syndrome, cannabidiol resulted in a greater reduction in convulsive-seizure frequency than placebo and was associated with higher rates of adverse events. (Funded by GW Pharmaceuticals; ClinicalTrials.gov number, NCT02091375.)
Article
Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (THC/CBD, Sativex®, nabiximols) is available in numerous countries worldwide for the treatment of multiple sclerosis (MS)-related moderate to severe spasticity in patients who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. Twelve weeks’ therapy with THC/CBD improved MS-related spasticity in patients with an inadequate response to other anti-spasticity agents who had undergone a successful initial trial of THC/CBD therapy, according to the results of a pivotal phase 3 trial. Improvements in spasticity were maintained in the longer term with THC/CBD with no evidence of dose tolerance, and results of real-world studies confirm the effectiveness of THC/CBD in everyday clinical practice. Improvements in health-related quality of life and activities of daily living were also seen with THC/CBD. THC/CBD is generally well tolerated; adverse effects such as dizziness may occur whilst the THC/CBD dosage is being optimized. THC/CBD has low abuse potential and a low risk of psychoactive effects. In conclusion, THC/CBD oromucosal spray is a useful option for the treatment of MS-related spasticity not completely relieved with current anti-spasticity medication.