Clinical trial NCT03274440: Effects of Marijuana on Symptoms of OCD
Official title: Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Marijuana
THC
Cannabis
CBD
Cannabinoid
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
timeFrame: 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:
measure: Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
timeFrame: 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.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Reilly Kayser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: