Effects of Marijuana on Symptoms of OCD (ECOS)

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ClinicalTrials.gov Identifier: NCT03274440

Recruitment Status : Completed

First Posted : September 7, 2017

Last Update Posted : June 19, 2019

Sponsor:

Information provided by (Responsible Party):

Reilly R. Kayser, New York State Psychiatric Institute

Study Description

Brief Summary:

The purpose of this pilot research study is to test whether certain components of the marijuana plant, known as "cannabinoids", may help to reduce symptoms in patients with OCD. Specifically, patients enrolled in the study will smoke marijuana containing different concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Neither compound is currently FDA-approved for treating OCD.

Condition or disease	Intervention/treatment	Phase
Obsessive-Compulsive Disorder	Drug: Marijuana Other: Placebo	Phase 1 Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
Actual Study Start Date :	October 1, 2017
Actual Primary Completion Date :	March 1, 2019
Actual Study Completion Date :	April 1, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Obsessive-compulsive disorder

MedlinePlus related topics: Marijuana Obsessive-Compulsive Disorder

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: High THC/Low CBD Marijuana This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content.	Drug: Marijuana THC and CBD are "cannabinoids" which are found naturally in the marijuana plant. Both act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.
Experimental: Low THC/High CBD Marijuana This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.	Drug: Marijuana THC and CBD are "cannabinoids" which are found naturally in the marijuana plant. Both act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.
Placebo Comparator: No THC/No CBD This condition involves the ingestion of a placebo control with no THC and no CBD content.	Other: Placebo Placebo control group, not receiving THC or CBD.

Outcome Measures

Primary Outcome Measures :

Yale-Brown Obsessive-Compulsive Challenge Scale [ Time Frame: Weeks 0, 1, 2, 3 ]
Change in the Yale-Brown Obsessive-Compulsive Challenge Scale

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 21-55
Physically healthy
Diagnosed with OCD
Current marijuana user
Women of childbearing potential must be using an effective form of birth control
Not currently taking psychotropic medications
Ability to provide informed consent

Exclusion Criteria:

History of any significant medical condition that may increase the risk of participation
Females who are pregnant or nursing
If female, not pregnant
Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
Current substance use disorder
Severe depression or positive urine toxicology (other than THC) at screening, or any adverse reaction to a cannabinoid
Patients who are seeking treatment for substance abuse
Patients who are planning to begin a course of cognitive-behavioral therapy within 8 weeks of beginning the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274440

Locations

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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

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Principal Investigator:	Reilly Kayser, M.D.	New York State Psychiatric Institute

More Information

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Responsible Party:	Reilly R. Kayser, Resident, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT03274440 History of Changes
Other Study ID Numbers:	# 7405
First Posted:	September 7, 2017 Key Record Dates
Last Update Posted:	June 19, 2019
Last Verified:	June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Reilly R. Kayser, New York State Psychiatric Institute:


OCD Marijuana THC	Cannabis CBD Cannabinoid

Additional relevant MeSH terms:

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Marijuana Abuse Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders	Mental Disorders Anxiety Disorders Substance-Related Disorders Chemically-Induced Disorders

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