Effects of Marijuana on Symptoms of OCD

NCT03274440 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: # 7405
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; Marijuana; THC; Cannabis; CBD; Cannabinoid

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)

  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).

  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.

Secondary Outcomes (1)

• Spielberger State-Trait Anxiety Scale: State Version (STAI-S)

  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.

Study Arms (3)

High THC/Low CBD Marijuana

EXPERIMENTAL

This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (\<1%) content.

Drug: Cannabis

Low THC/High CBD Marijuana

EXPERIMENTAL

This condition involves the ingestion of marijuana with a low THC (\<1%) and high CBD (\>10%) content.

Drug: Cannabis

No THC/No CBD

PLACEBO COMPARATOR

This condition involves the ingestion of a placebo control with no THC and no CBD content.

Other: Placebo

Interventions

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.

Also known as: marijuana

High THC/Low CBD Marijuana; Low THC/High CBD Marijuana

Placebo OTHER

Placebo control group, not receiving THC or CBD.

No THC/No CBD

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Reilly Kayser
• Organization: Columbia University/New York State Psychiatric Institute

reilly.kayser@nyspi.columbia.edu

6467748118

Study Officials

• Reilly Kayser, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: October 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: October 29, 2020
• Last Updated: November 18, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)