Clinical trial

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

Name
7809
Description
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.
Trial arms
Trial start
2022-03-01
Estimated PCD
2024-05-08
Trial end
2024-05-08
Status
Withdrawn
Phase
Early phase I
Treatment
Nabilone
Half of the participants (30 individuals) will receive nabilone 1mg. Nabilone will be placed in opaque capsules with dextrose filler and administered by mouth only once (around 120 minutes prior to fMRI scanning).
Arms:
Nabilone
Other names:
Cesamet (brand name)
Placebo
Half of the participants (30 individuals) will receive placebo capsules that are opaque and contain only dextrose. Placebo capsules will be administered by mouth only once (around 120 minutes prior to fMRI scanning).
Arms:
Placebo
Primary endpoint
Brain Measure 1
5 years
Brain Measure 2
5 years
Skin conductance response (SCR)
5 years
Electromyography (EMG)
5 years
Expectancy Ratings
5 years
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-05-21

1 organization

1 product

1 drug

1 indication

Product
Nabilone