Effects of Marijuana on Symptoms of OCD (ECOS)

New York State Psychiatric Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Cannabis; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03274440

# 7405

Details and patient eligibility

About

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.

Full 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).

Enrollment: 14 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 3 patient groups, including a placebo group

High THC/Low CBD Marijuana

Experimental group

Description:

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

Treatment:

Drug: Cannabis

Low THC/High CBD Marijuana

Experimental group

Description:

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

Treatment:

Drug: Cannabis

No THC/No CBD

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo