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Effects of Marijuana on Symptoms of OCD

NCT ID: NCT03274440

Last Updated: 2020-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-10-29

Brief Summary

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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

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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).

Conditions

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Obsessive-Compulsive Disorder

Keywords

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OCD Marijuana THC Cannabis CBD Cannabinoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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High THC/Low CBD Marijuana

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

Group Type EXPERIMENTAL

Cannabis

Intervention Type 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.

Low THC/High CBD Marijuana

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

Group Type EXPERIMENTAL

Cannabis

Intervention Type 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.

No THC/No CBD

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo control group, not receiving THC or CBD.

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo control group, not receiving THC or CBD.

Intervention Type OTHER

Other Intervention Names

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marijuana

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Reilly R. Kayser

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reilly Kayser, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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# 7405

Identifier Type: -

Identifier Source: org_study_id