Obsessive-Compulsive Disorder
Conditions
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.
Interventions
DRUGNabilone
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.
BEHAVIORALExposure 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.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Yale-Brown Obsessive Compulsive Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | Through study completion, an average of 1 year. | Number of eligible participants recruited per month over a 1 year period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Nabilone | Nabilone and EX/RP | Total |
|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 14.6 | 30.8 years STANDARD_DEVIATION 10.4 | 33.4 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton Depression Rating Scale, 17-Item (HDRS-17) | 6.5 units on a scale STANDARD_DEVIATION 5.3 | 5.0 units on a scale STANDARD_DEVIATION 1 | 5.8 units on a scale STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) | 26.5 units on a scale STANDARD_DEVIATION 4.2 | 25.4 units on a scale STANDARD_DEVIATION 5 | 26.0 units on a scale STANDARD_DEVIATION 4.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 1 / 9 | 2 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
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
Time frame: Baseline (Week 0) and Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nabilone | Change in Yale-Brown Obsessive Compulsive Scale | Week 4 YBOCS Score | 24.0 score on a scale | Standard Deviation 6.9 |
| Nabilone | Change in Yale-Brown Obsessive Compulsive Scale | YBOCS Change | 2.5 score on a scale | Standard Deviation 3.6 |
| Nabilone and EX/RP | Change in Yale-Brown Obsessive Compulsive Scale | Week 4 YBOCS Score | 14.2 score on a scale | Standard Deviation 4.8 |
| Nabilone and EX/RP | Change in Yale-Brown Obsessive Compulsive Scale | YBOCS Change | 11.2 score on a scale | Standard Deviation 3.4 |
Secondary
Feasibility of Recruitment
Number of eligible participants recruited per month over a 1 year period.
Time frame: Through study completion, an average of 1 year.
Population: 16 total participants were recruited for participation in this study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nabilone | Feasibility of Recruitment | 0.73 participants per month |