Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, Marijuana, THC, Cannabis, CBD, Cannabinoid
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).
Interventions
DRUGCannabis
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.
OTHERPlacebo
Placebo control group, not receiving THC or CBD.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety). |
Countries
United States
Participant flow
Recruitment details
Participants were randomized to receive high THC/low CBD cannabis (THC), low THC/high CBD cannabis (CBD), and placebo cannabis (PBO). Total participants for each order were: Order A (THC, CBD, PBO) = 3 Order B (THC, PBO, CBD) = 2 Order C (CBD, THC, PBO) = 4 Order D (CBD, PBO, THC) = 1 Order E (PBO, THC, CBD) = 1 Order F (PBO, CBD, THC) = 3
Pre-assignment details
Participants who met study criteria and chose to participate were assigned to receive each of the three study conditions (high THC/low CBD; low THC/high CBD; placebo with no THC or CBD) in random order. All sessions were separated by at least 1 calendar week.
Participants by arm
| Arm | Count |
|---|---|
| All Participants In this within-subjects study, all participants received all three study drugs in random order. Demographic data is provided for all study participants together. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Time commitment too great | 1 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 7.4 |
| Cannabis use at time of enrollment | 3.8 days per week STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hamilton Depression Rating Scale, 17-Item (HDRS-17) | 4.9 units on a scale STANDARD_DEVIATION 4.7 |
| Medication Status Selective Serotonin Reuptake Inhibitor (SSRI) | 2 Participants |
| Medication Status Unmedicated | 10 Participants |
| Psychiatric Comorbidity Generalized Anxiety Disorder (GAD) | 2 Participants |
| Psychiatric Comorbidity Major Depressive Disorder (MDD) | 2 Participants |
| Psychiatric Comorbidity None | 8 Participants |
| Psychiatric Comorbidity Panic Disorder | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
| Speilberger State-Trait Anxiety Scale, Trait Version (STAI-T) | 48.5 units on a scale STANDARD_DEVIATION 13.9 |
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) | 20.1 units on a scale STANDARD_DEVIATION 4.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 20 | 13.36 score on a scale | Standard Deviation 10.15 |
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 180 | 10.18 score on a scale | Standard Deviation 6.35 |
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 90 | 9.00 score on a scale | Standard Deviation 4.8 |
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 0 (baseline) | 17.45 score on a scale | Standard Deviation 7.46 |
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 120 | 9.00 score on a scale | Standard Deviation 5.44 |
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 60 | 10.18 score on a scale | Standard Deviation 5.9 |
| High THC/Low CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 40 | 11.09 score on a scale | Standard Deviation 6.82 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 60 | 11.18 score on a scale | Standard Deviation 10.15 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 0 (baseline) | 17.00 score on a scale | Standard Deviation 8.07 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 20 | 11.55 score on a scale | Standard Deviation 9.46 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 40 | 11.64 score on a scale | Standard Deviation 9.91 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 90 | 9.91 score on a scale | Standard Deviation 7.62 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 120 | 9.64 score on a scale | Standard Deviation 5.89 |
| Low THC/High CBD Marijuana (Cannabis) | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 180 | 11.64 score on a scale | Standard Deviation 10.12 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 120 | 11.09 score on a scale | Standard Deviation 6.8 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 60 | 9.27 score on a scale | Standard Deviation 3.69 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 0 (baseline) | 17.09 score on a scale | Standard Deviation 4.16 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 180 | 10.00 score on a scale | Standard Deviation 4.77 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 40 | 9.00 score on a scale | Standard Deviation 2.59 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 90 | 12.18 score on a scale | Standard Deviation 7.44 |
| No THC/No CBD | Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS) | Minute 20 | 10.91 score on a scale | Standard Deviation 3.7 |
Comparison: Test for interaction effect between condition and time (includes all three groups and all time points)p-value: 0.577Linear mixed effects regression
Comparison: Test for main effect of time (includes all three groups and all time points)p-value: <0.001Linear mixed effects regression
Comparison: Test for main effect of condition (includes all three groups and all time points)p-value: 0.72Linear mixed effects regression
Secondary
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 20 | 40.00 score on a scale | Standard Deviation 21.37 |
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 90 | 34.91 score on a scale | Standard Deviation 11.48 |
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 60 | 33.00 score on a scale | Standard Deviation 10.49 |
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 0 (baseline) | 44.18 score on a scale | Standard Deviation 15.37 |
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 180 | 35.18 score on a scale | Standard Deviation 10.65 |
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 120 | 35.09 score on a scale | Standard Deviation 12.47 |
| High THC/Low CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 40 | 36.00 score on a scale | Standard Deviation 13.54 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 60 | 36.82 score on a scale | Standard Deviation 14.83 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 0 (baseline) | 45.00 score on a scale | Standard Deviation 14.3 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 20 | 37.55 score on a scale | Standard Deviation 15.28 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 40 | 36.00 score on a scale | Standard Deviation 15.63 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 90 | 34.64 score on a scale | Standard Deviation 10.56 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 120 | 35.18 score on a scale | Standard Deviation 8.67 |
| Low THC/High CBD Marijuana (Cannabis) | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 180 | 37.45 score on a scale | Standard Deviation 15.64 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 90 | 35.91 score on a scale | Standard Deviation 10.17 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 20 | 29.73 score on a scale | Standard Deviation 7.64 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 180 | 32.45 score on a scale | Standard Deviation 9.27 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 120 | 34.09 score on a scale | Standard Deviation 9.74 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 60 | 32.27 score on a scale | Standard Deviation 9.77 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 40 | 29.36 score on a scale | Standard Deviation 7.37 |
| No THC/No CBD | Spielberger State-Trait Anxiety Scale: State Version (STAI-S) | Minute 0 (baseline) | 42.27 score on a scale | Standard Deviation 10.87 |
Comparison: Test for interaction between condition and timep-value: 0.577Linear mixed effects regression
Comparison: Test for main effect of timep-value: <0.001Linear mixed effects regression
Comparison: Test for main effect of conditionp-value: 0.002Linear mixed effects regression