Obsessive-Compulsive Disorder Clinical Trial
Official title:
Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (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.
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.
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