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Completed

NCT Number: NCT02911324

Cannabinoid Medication for Adults With OCD

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nabilone

Drug

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: Cesamet (brand name)

Exposure and response prevention therapy

Behavioral

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.

Primary outcomes

  1. Change in Yale-Brown Obsessive Compulsive Scale

    Time frame: Baseline (Week 0) and Week 4

    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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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