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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nabilone | Experimental | Will receive nabilone at 1 mg daily (BID) over 4 weeks. |
|
| Nabilone and EX/RP | Experimental | Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabilone | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Yale-Brown Obsessive Compulsive Scale | 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 | Baseline (Week 0) and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Number of eligible participants recruited per month over a 1 year period. | Through study completion, an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen B Simpson, M.D., Ph.D. | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nabilone | Will receive nabilone at 1 mg daily (BID) over 4 weeks. 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. |
| FG001 | Nabilone and EX/RP | Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One participant in the nabilone+EX/RP group completed the study, but was not included in the final analysis due to inconsistent self-reporting of symptoms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nabilone | Will receive nabilone at 1 mg daily (BID) over 4 weeks. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Yale-Brown Obsessive Compulsive Scale | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0) and Week 4 |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nabilone | Will receive nabilone at 1 mg daily (BID) over 4 weeks. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Nervous system disorders | Systematic Assessment |
Small sample size and observational design limits generalizability of data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reilly Kayser, MD | Columbia University/New York State Psychiatric Institute | 646-774-8118 | reilly.kayser@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 7, 2020 | Feb 13, 2020 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2016 | Feb 13, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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|
| Exposure and Response Prevention Therapy | 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. |
|
| Nabilone and EX/RP |
Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks. 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) | Measure of OCD symptom severity. Total YBOCS scores are reported. Scores range from 0 - 40, with higher scores representing more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Depression Rating Scale, 17-Item (HDRS-17) | Measure of depression symptom severity. Total HDRS-17 scores are reported. Scores range from 0-52, with higher scores representing greater symptom severity. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Feasibility of Recruitment | Number of eligible participants recruited per month over a 1 year period. | 16 total participants were recruited for participation in this study | Posted | Number | participants per month | Through study completion, an average of 1 year. |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Nabilone and EX/RP | Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks. 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. 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. | 0 | 7 | 0 | 7 | 2 | 7 |
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