Cannabinoid Medication for Adults With OCD

NCT ID: NCT02911324

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-01-31

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.

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nabilone

Will receive nabilone at 1 mg daily (BID) over 4 weeks.

Group Type: EXPERIMENTAL

Nabilone

Intervention Type: 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.

Nabilone and EX/RP

Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.

Group Type: EXPERIMENTAL

Nabilone

Intervention Type: 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.

Exposure and Response Prevention Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cesamet (brand name)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Reilly R. Kayser

Resident of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen B Simpson, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

7239

Identifier Type: -

Identifier Source: org_study_id