Effects of Marijuana on Symptoms of OCD

Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder

Sponsors

Lead Sponsor: New York State Psychiatric Institute

Source New York State Psychiatric Institute
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

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).

Overall Status Completed
Start Date 2017-10-01
Completion Date 2020-10-29
Primary Completion Date 2019-03-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) 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 Outcome
Measure Time Frame
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.
Enrollment 14
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cannabis

Description: 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 Name: marijuana

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo control group, not receiving THC or CBD.

Arm Group Label: No THC/No CBD

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

55 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Reilly Kayser, M.D. Principal Investigator New York State Psychiatric Institute
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: New York State Psychiatric Institute
Location Countries

United States

Verification Date

2020-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: New York State Psychiatric Institute

Investigator Full Name: Reilly R. Kayser

Investigator Title: Resident

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: High THC/Low CBD Marijuana

Type: Experimental

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

Label: Low THC/High CBD Marijuana

Type: Experimental

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

Label: No THC/No CBD

Type: Placebo Comparator

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

Acronym ECOS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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