Clinical trial NCT02911324: Cannabinoid Medication for Adults With OCD
Official title: Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Yale-Brown Obsessive Compulsive Scale
timeFrame: Baseline (Week 0) and Week 4
Secondary outcomes:
measure: Feasibility of Recruitment
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Helen B Simpson, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: