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.
Cesamet (brand name)Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-08-06
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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.
Cesamet (brand name)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.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Nabilone | 6 | 24.0 | 6.9 |
| Nabilone and EX/RP | 5 | 14.2 | 4.8 |
| Nabilone | 6 | 2.5 | 3.6 |
| Nabilone and EX/RP | 5 | 11.2 | 3.4 |
Number of eligible participants recruited per month over a 1 year period.
Population: 16 total participants were recruited for participation in this study
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Flow | 16 | 0.73 | - |
| Milestone | Nabilone | Nabilone and EX/RP |
|---|---|---|
| STARTED | 9 | 7 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 3 | 1 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Anxiety | Nervous system disorders | Nabilone: 1 / 9 · Nabilone and EX/RP: 2 / 7 |
Eligibility
primary outcomes
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 outcomes
Time frame: Through study completion, an average of 1 year.
Number of eligible participants recruited per month over a 1 year period.
Publications
No exact PMID-linked public article is currently readable locally.