Trial Outcomes & Findings for Cannabinoid Medication for Adults With OCD (NCT NCT02911324)
NCT ID: NCT02911324
Last Updated: 2020-08-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline (Week 0) and Week 4
Results posted on
2020-08-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cannabinoid Medication for Adults With OCD
Baseline characteristics by cohort
| Measure |
Nabilone
n=6 Participants
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.
|
Nabilone and EX/RP
n=5 Participants
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
|
26.5 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
25.4 units on a scale
STANDARD_DEVIATION 5.0 • n=7 Participants
|
26.0 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Hamilton Depression Rating Scale, 17-Item (HDRS-17)
|
6.5 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 4Yale-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
Outcome measures
| Measure |
Nabilone
n=6 Participants
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.
|
Nabilone and EX/RP
n=5 Participants
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.
|
|---|---|---|
|
Change in Yale-Brown Obsessive Compulsive Scale
Week 4 YBOCS Score
|
24.0 score on a scale
Standard Deviation 6.9
|
14.2 score on a scale
Standard Deviation 4.8
|
|
Change in Yale-Brown Obsessive Compulsive Scale
YBOCS Change
|
2.5 score on a scale
Standard Deviation 3.6
|
11.2 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 year.Population: 16 total participants were recruited for participation in this study
Number of eligible participants recruited per month over a 1 year period.
Outcome measures
| Measure |
Nabilone
n=16 Participants
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.
|
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.
|
|---|---|---|
|
Feasibility of Recruitment
|
0.73 participants per month
|
—
|
Adverse Events
Nabilone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nabilone and EX/RP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nabilone
n=9 participants at risk
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.
|
Nabilone and EX/RP
n=7 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 18 months
|
28.6%
2/7 • Number of events 2 • 18 months
|
Additional Information
Reilly Kayser, MD
Columbia University/New York State Psychiatric Institute
Phone: 646-774-8118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place