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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
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 7, 2017
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
Yale-Brown Obsessive-Compulsive Challenge Scale [ Time Frame: Weeks 0, 1, 2, 3 ]
Change in the Yale-Brown Obsessive-Compulsive Challenge Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Marijuana on Symptoms of OCD
Official Title  ICMJE Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • 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.
  • Other: Placebo
    Placebo control group, not receiving THC or CBD.
Study Arms  ICMJE
  • Experimental: High THC/Low CBD Marijuana
    This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content.
    Intervention: Drug: Marijuana
  • Experimental: Low THC/High CBD Marijuana
    This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.
    Intervention: Drug: Marijuana
  • Placebo Comparator: No THC/No CBD
    This condition involves the ingestion of a placebo control with no THC and no CBD content.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: June 17, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)
20
Estimated Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03274440
Other Study ID Numbers  ICMJE # 7405
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reilly Kayser, M.D. New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP