Clinical trial NCT03274440
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD Marijuana THC Cannabis CBD Cannabinoid
Sponsor: New York State Psychiatric Institute
Start date: 2017-10-01; Completion date: 2020-10-29
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this pilot research study is to test whether certain components of the marijuana plant, known as "cannabinoids", may help to reduce symptoms in patients with OCD. Specifically, patients enrolled in the study will smoke marijuana containing different concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Neither compound is currently FDA-approved for treating OCD.

Detailed description:
Prior research suggests that certain areas of the brain are receptive to chemicals like those found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be involved in anxiety disorders and OCD. More recent data shows that synthetic drugs that target these systems may be helpful in conditions related to OCD like anxiety disorders and Tourette's syndrome. Thus, these substances could also possibly be useful to treat OCD symptoms. However, to date there has been little research regarding the role of cannabinoids in OCD.

The purpose of this study is to examine the effects of different cannabinoids on OCD symptoms in humans. To accomplish this in a laboratory setting, patients with OCD who are also occasional cannabis users will receive different combinations of two of the most well-studied cannabinoids, delta-9-tetrahydrocannabinol (THC, the main psychoactive component in cannabis) and cannabidiol (CBD, another component of the cannabis plant). We will then measure acute effects on OCD symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood pressure and heart rate).

Arms: arm 1: This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (\<1%) content. arm 2: This condition involves the ingestion of marijuana with a low THC (\<1%) and high CBD (\>10%) content. arm 3: This condition involves the ingestion of a placebo control with no THC and no CBD content.
Interventions: intervention 1: Cannabis intervention 2: Placebo
Intervention descriptions: intervention 1: THC and CBD are "cannabinoids" which are found naturally in the marijuana plant. Both act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. intervention 2: Placebo control group, not receiving THC or CBD.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
Summary Page 
 
 
 
Title: Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder 
Protocol #: NCT03274440 
Document Date: 5/10/2018 
Documents Included: 
1. Study Protocol 
2. Consent Form 
3. Data Analytic Plan 
 










































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CONSENT FORM
Informed Consent for Participation in Research 
Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder 
 
Purpose and Overview 
You are being asked to take part in a research study because you have symptoms of Obsessive Compulsive 
Disorder (OCD) and these symptoms cause difficulties in your daily activities. Before you choose whether or not 
to take part, it is important for you to understand why this research is being done, and what it will involve. Please
take time to read the following information carefully and ask the study doctor any questions that you may have 
about this research study.   
This research study is designed to examine whether smoked marijuana affects OCD symptoms. Marijuana 
contains a number of compounds called cannabinoids that are thought to interact with certain regions of the brain 
that are involved in OCD. The goal of this study is to see how marijuana affects OCD symptoms. It is not designed 
to provide treatment of your OCD. A total of 20 adults between the ages of 21 and 55 years who have OCD and 
who are also occasional marijuana smokers will participate in the study. If you are a woman, you will confirm 
that you are not pregnant and are using an effective form of birth control (for example, condoms or hormonal 
contraceptives). 
Voluntary 
Participation in this research study is voluntary.  If you decide not to participate, or if you later decide to stop 
participating, you will not lose any benefits to which you are otherwise entitled.  A decision not to participate or 
withdraw your participation will not affect your current or future treatment at the New York State Psychiatric 
Institute or Columbia University.  
Alternative Treatments/Alternatives to Participation  
This is not a treatment study. Information is being collected for research purposes only and to learn more about 
how marijuana affects OCD symptoms. The study will not provide information that will be medically useful for 
you. The alternative to participating would be simply not to participate.  
You do not have to participate in this study to receive treatment for OCD. Medicines called Serotonin Reuptake 
Inhibitors (SRIs) are available for the treatment of OCD. In addition, there is a form of therapy called Cognitive 
Behavior Therapy, which has been found to be effective in treating OCD. If you decide not to participate in this 
study, you may choose to be treated with one or more of these therapies (on your own), or not seek further 
treatment. If you wish, we can provide a list of other doctors, therapists and/or treatment facilities in the 
community who offer these treatments. 
Procedures  
 
Screening: As part of the routine screening done in the Anxiety Disorders Clinic, you have already met with staff 
of the Anxiety Disorders Clinic to discuss your medical and psychiatric history. You were given an interview and 
have undergone a complete physical exam, routine bloods, urinalysis, electrocardiogram, pregnancy test (if 
female), and a urine drug screen sample. If after this screening process, you are eligible to participate in this study 
and you agree to participate, you will be asked to sign this consent form.  
Study Procedures:  
The study consists of 3 laboratory sessions, and in each session we will ask you to smoke a marijuana 
cigarette. The strength of the marijuana you smoke in each session will vary. It will contain different levels of 
THC, which is the major active ingredient in marijuana, and cannabidiol, another component of the marijuana 
plant. Neither you nor the research staff will know during the laboratory session which strength of marijuana 


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you received. We do not tell the strength of the marijuana you will receive in advance, as this knowledge may 
affect your response. 
Laboratory sessions (a total of 3) will be conducted once or twice per week depending on your availability. 
You will need to arrive at the laboratory in the morning and stay for about 4 hours. You will receive a different 
strength of marijuana in each session. We will collect data concerning your heart rate and blood pressure, your 
mood, and your OCD symptoms.  
It is important that you do not smoke marijuana the morning before coming in for a session. Thus, if you smoke 
marijuana the night before a session, you must stop smoking by midnight on the day of the session, so that there 
will be at least 10 hours between your marijuana use at home and in the laboratory.   
We need to confirm that you are free of recent marijuana or alcohol use to ensure the scientific integrity of our 
study. Therefore, before each session we will ask you to provide a urine sample that may be screened for drug 
use. You will also have your breath alcohol, carbon monoxide and possibly saliva measured in order to verify 
that you have not smoked marijuana or had any alcohol shortly before a session, as the presence of these 
substances may affect your response in the laboratory. If you are a woman, you will also have a urine pregnancy 
test prior to each session. 
You will need to complete the questionnaires at the scheduled times. When you are not filling out 
questionnaires, you may engage in activities such as reading and homework, as long as these activities do not 
interfere with the protocol.  
At the end of each smoking session, you may or may not still have a drug effect. For your safety, the research 
staff will evaluate you and decide if you are able to leave. If you are still having a drug effect you may be asked 
to stay longer until the drug effects wear off; you will be paid at a rate of $10/hour for any extra time. You will 
not be allowed to drive a car for 8 hours after drug administration so you need to be picked up by a relative or 
friend, or you will need to take a bus or subway to your destination. We will pay for mass-transit expenses in 
cash during each visit in a total of $6.00 per visit (to cover $2.75 subway fare to and from the laboratory). 
Depending on our evaluation of any remaining drug effect, we may also arrange for a taxi to take you to your 
destination, and we will reimburse you for these expenses when you provide us with a receipt for the taxi fare. 
These are safety precautions for your benefit. Failure to follow our advice could result in termination from the 
study. 
Risks and Inconveniences 
You may experience side effects from the marijuana, which could include: increased appetite, sleepiness, 
concentration difficulties, faintness, restlessness, confusion, lightheadedness, loss of coordination, clumsiness, 
shakiness, dizziness, stomach upset, headache, paleness, flushing, sweating, dry mouth, slurred speech, fatigue, 
itching, heart pounding, and changes in the pattern of heart beats. We will watch you carefully throughout your 
laboratory sessions to minimize the chance of any serious reactions.  
Some of the marijuana that you smoke will contain higher amounts of cannabidiol relative to THC (the active 
ingredient in marijuana). Like THC, cannabidiol is a natural part of the marijuana plant, and there is little 
evidence that it has many direct effects, although it is possible that you may feel sleepy. Cannabidiol is not 
listed as a carcinogen (a substance that causes cancer) by the International Agency for Research on Cancer. 
However, exposure to THC or cannabidiol may have a harmful effect on a fetus or a newborn, and therefore 
you will not be allowed to participate in the study if you are pregnant or breastfeeding during the study. You 
will be asked to confirm that are using an effective form of birth control while you are participating in the study.


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Benefits 
This study is not designed to benefit you directly, and we do not know whether or not your symptoms of OCD 
will improve while in this study. The benefits of this research relate primarily to your participation contributing 
to our understanding the effect of marijuana on symptoms of OCD in adults.   
Confidentiality  
Your records will be kept in locked files and will be kept confidential. Records will be available to research 
staff, and to Federal, State and Institutional regulatory personnel (who may review records as part of routine 
audits). Your name and other personal identifying information will be stored in an electronically secure 
database at New York State Psychiatric Institute. All data will be stored separately from any identifying 
information and will be password protected. Information about you may be transferred through the internet, but 
only a code number and your initials will be used to identify you. In reporting the results of this study, privacy 
is protected by reporting group results or by using coding systems that do not reveal the identity of individuals 
when individual results are reported. Your name or address is never reported. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this Web site at any time. 
Study Compensation  
For participating in this research you will receive cash for each laboratory session you complete. You will earn 
$25 for each session, and an additional bonus of $50 if you complete the study. If you withdraw early you will 
not receive the bonus payment. Session pay will be given in cash at the end of each session. If you do not follow 
the study protocol, you may be removed from the study. In total, the pay for study participation will be $125 for 
completion of all sessions. You will also be reimbursed for public transportation after each laboratory session. 
In Case of Injury 
If you believe that you have sustained an injury as a result of participating in a research study, you may contact 
the Principal Investigator at (646) 774-6369 so that you can review the matter and identify the medical 
resources that may be available to you. 
Please be aware that: 
1. The New York State Psychiatric Institute, Columbia University and New York Presbyterian Hospital 
will furnish that emergency medical care determined to be necessary by the medical staff of this hospital 
2. You will be responsible for the cost of such care, either personally or through your medical insurance or 
other form of medical coverage. 
3. No monetary compensation for wages lost as a result of injury will be paid to you by the New York 
State Psychiatric Institute, Columbia University or by New York Presbyterian Hospital. 
4. By signing this consent form, you are not waiving any of your legal rights to seek compensation through 
the courts. 
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not provide 
compensation or payment for treatment of research related injuries.  However, you should be aware that you do 
not give up your legal right to seek such compensation through the court by participating in this research. 


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Questions
For questions or emergencies, Dr. Reilly Kayser is available to answer your questions about the study at any 
time.  Dr. Kayser can be reached during the day at (646) 774-6369.  After 5 P.M. you can page the Anxiety 
Clinic Doctor on Call at (917) 786-6939.  
If you have any questions about your rights as a research participant, want to provide feedback, or have a 
complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a committee that protects the 
rights of human subjects in research studies). You may call the IRB Main Office at (646) 774-7155 during 
regular office hours.  
Documentation of Consent  
Statement of consent 
I have discussed the study described above with _________________ to my satisfaction. To the best of my 
knowledge, I am not pregnant. I understand that my participation is voluntary, and that I can withdraw from the 
study at any time without prejudice. Signing this form does not waive any of my legal rights. I have read the 
above, and I voluntarily agree to participate in this research study. 
Print name: __________________ 
Signed: _____________________ 
Date: _______________________ 
Statement of Investigator Obtaining Consent 
I have discussed the proposed research with this participant including the risks, benefits, and alternatives to 
participation (including the alternative of not participating in the research).  The participant has had an 
opportunity to ask questions and in my opinion is capable of freely consenting to participate in this research.  
Print name: ________________ 
Person Designated to Obtain Consent  
Signed: ___________________ 
Date: _____________________ 


7405
Reilly Kayser, MD
Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
Anxiety Disorders Clinic, NYSPI


Reilly Kayser, MD
New York State Psychiatric Institute
1051 Riverside Drive, Office 1303A
New York, NY 10032


Data Analytic Plan 
Demographics: The distribution of demographic variables and baseline clinical characteristics 
will be examined and described across the sample in terms of means, SDs, proportions, and 95% 
confidence intervals.  
Cannabis Effects: We will use a random-effects linear mixed model to evaluate changes in each 
continuous outcome (YBOCCS, OCD-VAS, STAI-S MRF, cardiovascular measures) as a 
function of condition (THC, CBD, placebo), time point, and their interaction. Mixed-effects 
modeling accounts for clustering of repeated measures within subjects, allows time to be 
modeled as a continuously rather than categorically, and has been used in similar acute 
pharmacological challenge studies (Rodriguez et al. 2013). The model will include participants 
as a random effect, condition and time as fixed within-subjects factors, the interaction between 
condition and time, and a random intercept. Given that the interval between sessions increases 
over the course of each session, we will model time as a continuous variable. We will use 
contrasts within each mixed-effects linear regression model to estimate differences in outcomes 
between both active cannabis varietals and placebo at different time points. All statistical tests 
will be conducted using an alpha level of 0.05, two-tailed.  
Other Effects: Though we have no a priori hypotheses about the effects of age, gender, 
comorbid diagnoses (e.g. MDD), or other factors that might influence our participants’ response 
to cannabis, we will nonetheless explore the possibility of such effects by including these factors 
as covariates in separate analyses.