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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 : Suspended (Principle Investigator was deployed to NYP to help with COVID-19 response team)
First Posted : September 7, 2017
Results First Posted : June 23, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Reilly R. Kayser, New York State Psychiatric Institute

Study Description
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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: Cannabis Other: Placebo Phase 1 Phase 2

Detailed Description:

Prior research suggests that certain areas of the brain are receptive to chemicals like those found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be involved in anxiety disorders and OCD. More recent data shows that synthetic drugs that target these systems may be helpful in conditions related to OCD like anxiety disorders and Tourette's syndrome. Thus, these substances could also possibly be useful to treat OCD symptoms. However, to date there has been little research regarding the role of cannabinoids in OCD.

The purpose of this study is to examine the effects of different cannabinoids on OCD symptoms in humans. To accomplish this in a laboratory setting, patients with OCD who are also occasional cannabis users will receive different combinations of two of the most well-studied cannabinoids, delta-9-tetrahydrocannabinol (THC, the main psychoactive component in cannabis) and cannabidiol (CBD, another component of the cannabis plant). We will then measure acute effects on OCD symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood pressure and heart rate).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover 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
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Cannabis
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.
Other Name: marijuana
Experimental: Low THC/High CBD Marijuana
This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.
 Drug: Cannabis
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.
Other Name: marijuana
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
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Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) [ Time Frame: Baseline was obtained at the beginning of each session. Then, change from baseline was measured following cannabis administration (minute 0) at minutes 20, 40, 60, 90, 120, and 180. This procedure was repeated for each of the 3 conditions. ]
    An adapted version of the Yale-Brown Obsessive-Compulsive Scale (YBOCS) which measures change in OCD symptoms over short time frames (i.e., since the last assessment as opposed to over the past week). Total score is reported. Scores range from 0 (no symptoms) to 40 (severe symptoms).


Secondary Outcome Measures :
  1. Spielberger State-Trait Anxiety Scale: State Version (STAI-S) [ Time Frame: Baseline obtained at the beginning of the session (Minutes 0), and then the scale was obtained at minutes 20, 40, 60, 90, 120, and 180 after cannabis administration. ]
    A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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
  Study Documents (Full-Text)

Documents provided by Reilly R. Kayser, New York State Psychiatric Institute:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] May 10, 2018

More Information
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Responsible Party: Reilly R. Kayser, Resident, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03274440    
Other Study ID Numbers: # 7405
First Posted: September 7, 2017    Key Record Dates
Results First Posted: June 23, 2020
Last Update Posted: August 6, 2020
Last Verified: July 2020
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