Effects of Marijuana on Symptoms of OCD (ECOS)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, Marijuana, THC, Cannabis, CBD, Cannabinoid
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High THC/Low CBD Marijuana
Low THC/High CBD Marijuana
No THC/No CBD
Arm Description
This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content.
This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.
This condition involves the ingestion of a placebo control with no THC and no CBD content.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).
Full Information
NCT ID
NCT03274440
First Posted
September 5, 2017
Last Updated
October 29, 2020
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT03274440
Brief Title
Effects of Marijuana on Symptoms of OCD
Acronym
ECOS
Official Title
Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
October 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, Marijuana, THC, Cannabis, CBD, Cannabinoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High THC/Low CBD Marijuana
Arm Type
Experimental
Arm Description
This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content.
Arm Title
Low THC/High CBD Marijuana
Arm Type
Experimental
Arm Description
This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.
Arm Title
No THC/No CBD
Arm Type
Placebo Comparator
Arm Description
This condition involves the ingestion of a placebo control with no THC and no CBD content.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
marijuana
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo control group, not receiving THC or CBD.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Description
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).
Time Frame
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 Information:
Title
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Description
A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reilly Kayser, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Marijuana on Symptoms of OCD
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