CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Nabilone +1 moredrug
Likely dose
Nabilone (specific dose not stated in interventions)AI-extracted
Key inclusion· 5
  • Age 18 to 60 years
  • Primary diagnosis of Obsessive-Compulsive Disorder
  • Physically healthy and not pregnant
  • Off all psychotropic medications except SSRIs, and off other drugs likely to interact with nabilone
Key exclusion· 6
  • Pregnant or nursing females
  • History of significant medical condition increasing risk of participation
  • Lifetime psychiatric disorder other than OCD (e.g., psychosis or bipolar disorder)
  • Current substance use disorder or positive urine toxicology at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02911324
NCT02911324Phase 2Completed

Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD)

New York State Psychiatric Institute·interventional·Posted Sep 22, 2016·Updated Aug 6, 2020

In Brief

A Phase 2 clinical trial evaluating Nabilone and Exposure and Response Prevention Therapy for Obsessive-Compulsive Disorder. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 22, 2016
Enrollment StartSep 1, 2016
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.8 years ago

Interventions

Nabilonedrug

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.

Exposure and Response Prevention Therapybehavioral

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.