NCT02911324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 28, 2020

Completed
Last Updated

August 6, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

September 12, 2016

Results QC Date

January 10, 2020

Last Update Submit

July 29, 2020

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Feasibility of Recruitment

    Through study completion, an average of 1 year.

Study Arms (2)

Nabilone

EXPERIMENTAL

Will receive nabilone at 1 mg daily (BID) over 4 weeks.

Drug: Nabilone

Nabilone and EX/RP

EXPERIMENTAL

Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.

Drug: NabiloneBehavioral: Exposure and Response Prevention Therapy

Interventions

NabiloneDRUG

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.

Also known as: Cesamet (brand name)
NabiloneNabilone and EX/RP
Exposure and Response Prevention TherapyBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

nabilone

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Limitations and Caveats

Small sample size and observational design limits generalizability of data

Results Point of Contact

Title
Reilly Kayser, MD
Organization
Columbia University/New York State Psychiatric Institute
reilly.kayser@nyspi.columbia.edu
646-774-8118

Study Officials

  • Helen B Simpson, M.D., Ph.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Psychiatry

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 22, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 6, 2020

Results First Posted

February 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)