Cannabinoid Medication for Adults With OCD
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ClinicalTrials.gov Identifier: NCT02911324 |
Recruitment Status :
Completed
First Posted : September 22, 2016
Results First Posted : February 28, 2020
Last Update Posted : August 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Obsessive-Compulsive Disorder | Drug: Nabilone Behavioral: Exposure and Response Prevention Therapy | Phase 1 Phase 2 |
The two first-line treatments for OCD are a class of medications called serotonin reuptake inhibitors (SRIs) and a type of cognitive behavioral therapy called exposure and response prevention (EX/RP). But more than a third of patients with OCD do not respond to these treatments, and less then half become well. Thus, new treatment approaches are needed.
EX/RP is thought to involve fear extinction learning. Recent research suggests that modulators of the endocannabinoid system such as nabilone (a synthetic cannabinoid and agonist of the cannabinoid 1 receptor, CB1R) may enhance fear extinction learning and therefor could enhance EX/RP. However, nabilone could also work via modulating activity in cortico-striatal circuits, which contain high concentrations of CB1R, and thereby might reduce repetitive behaviors like compulsions seen in OCD.
To test both ideas, we will conduct a small pilot randomized trial to explore the effects of nabilone on its own for 4 weeks, vs. combined with EX/RP, in adult patients with OCD. This proof-of-concept study will investigate whether nabilone administration is feasible and well-tolerated in adult patients with OCD. The intent is to collect pilot data to support future grant applications.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD) |
Study Start Date : | September 2016 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
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Experimental: Nabilone
Will receive nabilone at 1 mg daily (BID) over 4 weeks.
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Drug: Nabilone
Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.
Other Name: Cesamet (brand name) |
Experimental: Nabilone and EX/RP
Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.
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Drug: Nabilone
Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.
Other Name: Cesamet (brand name) Behavioral: Exposure and Response Prevention Therapy Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions. |
- Change in Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline (Week 0) and Week 4 ]
Yale-Brown Obsessive Compulsive Scale (YBOCS) Minimum Value: 0 Maximum Value: 40 Higher scores indicate more severe symptoms
Change in YBOCS is calculated by subtracting the Week 4 score from the baseline score
- Feasibility of Recruitment [ Time Frame: Through study completion, an average of 1 year. ]Number of eligible participants recruited per month over a 1 year period.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-60
- Physically healthy, not pregnant
- Primary Obsessive-Compulsive Disorder (OCD)
- Patient off all psychotropic (except selective serotonin reuptake inhibitors [SSRIs]) and other types of drugs likely to interact with nabilone
- Ability to provide informed consent
- Ability to tolerate a treatment free-period
Exclusion Criteria:
- History of any significant medical condition that may increase the risk of participation
- Females who are pregnant or nursing
- Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
- Current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid
- Patients already receiving EX/RP

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911324
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Helen B Simpson, M.D., Ph.D. | New York State Psychiatric Institute |
Documents provided by Reilly R. Kayser, New York State Psychiatric Institute:
Responsible Party: | Reilly R. Kayser, Resident of Psychiatry, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT02911324 |
Other Study ID Numbers: |
7239 |
First Posted: | September 22, 2016 Key Record Dates |
Results First Posted: | February 28, 2020 |
Last Update Posted: | August 6, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders Nabilone Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |