Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to test how a medication called nabilone (Cesamet) affects neurocognitive processes involved in obsessive-compulsive disorder (OCD), including threat response, processing of fear signals, and habitual behavior. OCD is a disabling illness that affects around 2% of the population and involves recurrent intrusive thoughts (obsessions) and repetitive behaviors (compulsions) that lead to distress and/or impaired functioning. Nabilone is a synthetic form of delta-9-tetrahydrocannabinol (THC, the primary psychoactive component of the cannabis plant). It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD symptoms. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.

In this study, 60 adults with OCD will receive a single dose of either nabilone or placebo. Participants will then complete a series of assessments including neuroimaging, psychophysiology (e.g., skin conductance recording), computerized behavioral tasks, and self-report measures. The information gained from this study could contribute to the development of new treatments for people with OCD and related disorders.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Nabilone

Criteria

Inclusion Criteria:

• Between 21-55 years of age

• Physically healthy and, if female, not pregnant

• Able to tolerate all study procedures

• Able to provide written informed consent to participate

• Right-handed

• Primary diagnosis of OCD

• Not taking psychotropic medications or other substances likely to interact with nabilone

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

• Positive urine toxicology or alcohol breathalyzer

• Any history of adverse reaction to a cannabinoid

• History of receiving cognitive behavior or exposure-based psychotherapy in the past 3 months

• History of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)

• History of claustrophobia or unable to tolerate confined spaces like an MRI