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Completed

NCT Number: NCT03274440

Effects of Marijuana on Symptoms of OCD

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.

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Key information

Conditions

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

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabis

Drug

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 names: marijuana

Placebo

Other

Placebo control group, not receiving THC or CBD.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder

Acronym: ECOS

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 7, 2017
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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