Cannabinoid Medication for Adults With OCD
Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nabilone
Will receive nabilone at 1 mg daily (BID) over 4 weeks.
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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 Names:
|
|
Experimental: Nabilone and EX/RP
Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.
|
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 Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Yale-Brown Obsessive Compulsive Scale
Time Frame: Baseline (Week 0) and Week 4
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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 |
Baseline (Week 0) and Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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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Through study completion, an average of 1 year.
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Collaborators and Investigators
Investigators
- Principal Investigator: Helen B Simpson, M.D., Ph.D., New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Anxiety Disorders
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Nabilone
Other Study ID Numbers
- 7239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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