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Effects of Marijuana on Symptoms of OCD (ECOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

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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


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.




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



Information from the National Library of Medicine

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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

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

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