Cannabinoid Medication for Adults With OCD

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02911324
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Drug: Nabilone; Behavioral: Exposure and Response Prevention Therapy	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD)
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nabilone Will receive nabilone at 1 mg daily (BID) over 4 weeks.	Drug: 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.; Other Names: Cesamet (brand name)
Experimental: Nabilone and EX/RP Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.	Drug: 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.; Other Names: Cesamet (brand name) ; Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Feasibility of Recruitment [Through study completion, an average of 1 year.]

   Number of eligible participants recruited per month over a 1 year period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: Helen B Simpson, M.D., Ph.D., New York State Psychiatric Institute

Study Documents (Full-Text)

• Study Protocol and Informed Consent Form - Jan 7, 2020
• Statistical Analysis Plan - May 23, 2016

More Information

Publications

None provided.

• Responsible Party: Reilly R. Kayser, Resident of Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02911324
• Other Study ID Numbers: 7239
• First Posted: Sep 22, 2016
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Nabilone

Study Results

Participant Flow

Arm/Group Title	Nabilone	Nabilone and EX/RP
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	9	7
COMPLETED	6	6
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Nabilone	Nabilone and EX/RP	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	6	5	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.5 (14.6)	30.8 (10.4)	33.4 (12.5)
Sex: Female, Male (Count of Participants)
Female	3 50%	1 20%	4 36.4%
Male	3 50%	4 80%	7 63.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 20%	1 9.1%
Not Hispanic or Latino	6 100%	4 80%	10 90.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 33.3%	1 20%	3 27.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 16.7%	0 0%	1 9.1%
White	3 50%	3 60%	6 54.5%
More than one race	0 0%	1 20%	1 9.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%	5 100%	11 100%
Yale-Brown Obsessive-Compulsive Scale (YBOCS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.5 (4.2)	25.4 (5.0)	26.0 (4.3)
Hamilton Depression Rating Scale, 17-Item (HDRS-17) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.5 (5.3)	5.0 (1.0)	5.8 (3.9)

Outcome Measures

1. Primary Outcome

Title	Change in Yale-Brown Obsessive Compulsive Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nabilone	Nabilone and EX/RP
Arm/Group Description	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.	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.
Measure Participants	6	5
Week 4 YBOCS Score	24.0 (6.9)	14.2 (4.8)
YBOCS Change	2.5 (3.6)	11.2 (3.4)

2. Secondary Outcome

Title	Feasibility of Recruitment
Description	Number of eligible participants recruited per month over a 1 year period.
Time Frame	Through study completion, an average of 1 year.

Outcome Measure Data

Analysis Population Description

16 total participants were recruited for participation in this study

Arm/Group Title	Flow
Arm/Group Description	# of participants enrolled per month
Measure Participants	16
Number [participants per month]	0.73 12.2%

Adverse Events

Time Frame	18 months
Arm/Group Title	Nabilone		Nabilone and EX/RP
Arm/Group Description	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.		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.
All Cause Mortality
	Nabilone		Nabilone and EX/RP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/7 (0%)
Serious Adverse Events
	Nabilone		Nabilone and EX/RP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Nabilone		Nabilone and EX/RP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		2/7 (28.6%)
Nervous system disorders
Anxiety	1/9 (11.1%)	1	2/7 (28.6%)	2

Limitations/Caveats

Small sample size and observational design limits generalizability of data

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.