Phase 2
N=16
Cannabinoid Medication for Adults With OCD
Obsessive-Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02911324 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change in Yale-Brown Obsessive Compulsive Scale — 24.0; 14.2; 2.5; 11.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nabilone (Drug); Exposure and Response Prevention Therapy (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Yale-Brown Obsessive Compulsive Scale |
24.0; 14.2; 2.5; 11.2 | — |
| SECONDARY Feasibility of Recruitment |
0.73 | — |
Summary
The purpose of this pilot research study is to test the effects of a medication called nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will receive either nabilone on its own, or nabilone in combination with a form of cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone is a synthetic cannabinoid and acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02911324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.