Cannabinoid Medication for Adults With OCD

• ClinicalTrials.gov Identifier: NCT02911324
• Recruitment Status: Completed
• First Posted: September 22, 2016
• Results First Posted: February 28, 2020
• Last Update Posted: August 6, 2020
• Sponsor: New York State Psychiatric Institute
• Information provided by (Responsible Party): Reilly R. Kayser, New York State Psychiatric Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obsessive-Compulsive Disorder	Drug: Nabilone; Behavioral: Exposure and Response Prevention Therapy	Phase 1; Phase 2

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD)
• Study Start Date: September 2016
• Actual Primary Completion Date: January 2019
• Actual Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nabilone; Will receive nabilone at 1 mg daily (BID) over 4 weeks.	Drug: Nabilone; 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 Name: Cesamet (brand name)
Experimental: Nabilone and EX/RP; Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.	Drug: Nabilone; 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 Name: Cesamet (brand name); Behavioral: Exposure and Response Prevention Therapy; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

• Principal Investigator: Helen B Simpson, M.D., Ph.D.; New York State Psychiatric Institute

  Study Documents (Full-Text)

Documents provided by Reilly R. Kayser, New York State Psychiatric Institute:

Study Protocol and Informed Consent Form  [PDF] January 7, 2020

Statistical Analysis Plan  [PDF] May 23, 2016

More Information

• Responsible Party: Reilly R. Kayser, Resident of Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02911324
• Other Study ID Numbers: 7239
• First Posted: September 22, 2016
• Results First Posted: February 28, 2020
• Last Update Posted: August 6, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Personality Disorders; Mental Disorders; Anxiety Disorders; Nabilone; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs