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Cannabinoid Medication for Adults With OCD

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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:
Information provided by (Responsible Party):
Reilly R. Kayser, New York State Psychiatric Institute

Study Description
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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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone

Arms and Interventions
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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
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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
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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911324


Locations
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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
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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
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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    Key Record Dates
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:
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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