Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High THC/Low CBD Marijuana | Experimental | This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content. |
|
| Low THC/High CBD Marijuana | Experimental | This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content. |
|
| No THC/No CBD | Placebo Comparator | This condition involves the ingestion of a placebo control with no THC and no CBD content. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reilly Kayser, M.D. | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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 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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Order A | Order A: THC, CBD, PBO. Cannabis: 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. |
| FG001 | Order B | Order B: THC, PBO, CBD. Cannabis: 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. |
| FG002 | Order C | Order C: CBD, THC, PBO. Cannabis: 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. |
| FG003 | Order D | Order D: CBD, PBO, THC. Cannabis: 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. |
| FG004 | Order E | Order E: PBO, THC, CBD. Cannabis: 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. |
| FG005 | Order F | Order F: PBO, CBD, THC. Cannabis: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics for all study completers
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
Over the course of all 3 sessions, an average of 38 days.
Participants in this preliminary study were randomized to receive high THC/low CBD cannabis ("THC"), low THC/high CBD cannabis ("CBD"), and inert placebo cannabis ("PBO"), in random order. The total number of participants who received each possible order is listed below:
Order A (THC, CBD, PBO) = 2 Order B (THC, PBO, CBD) = 2 Order C (CBD, THC, PBO) = 4 Order D (CBD, PBO, THC) = 0 Order E (PBO, THC, CBD) = 1 Order F (PBO, CBD, THC) = 3
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High THC/Low CBD Cannabis | Adverse events after receiving High THC (5-10%)/Low CBD (<1%) cannabis |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reilly Kayser | Columbia University/New York State Psychiatric Institute | 6467748118 | reilly.kayser@nyspi.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 10, 2018 | Apr 23, 2020 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C587251 | nabiximols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Placebo control group, not receiving THC or CBD. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Psychiatric Comorbidity | Comorbid psychiatric conditions (other than OCD) | Count of Participants | Participants |
|
| Medication Status | Number of patients taking psychotropic medication | Count of Participants | Participants |
|
| Cannabis use at time of enrollment | Self-reported cannabis use (number of days per week) at time of enrollment | Mean | Standard Deviation | days per week |
|
| Yale-Brown Obsessive-Compulsive Scale (YBOCS) | A scale measuring OCD symptom severity. Total score is reported and ranges from 0 (no symptoms) to 40 (severe symptoms). Scores >16 are consistent with clinical OCD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Speilberger State-Trait Anxiety Scale, Trait Version (STAI-T) | A scale measuring trait anxiety. Total score is reported and ranges from 20 (no trait anxiety) to 80 (severe trait anxiety). The norm for adults is 34.9+/-9.2. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Depression Rating Scale, 17-Item (HDRS-17) | A scale measuring depression symptoms. Total score is reported and ranges from 0 (no depression) to 52 (most severe depression). Anchors: 0-7 = no depression 8-16 = mild depression 17-25 = moderate depression >25 = severe depression | Mean | Standard Deviation | units on a scale |
|
| OG001 | Low THC/High CBD Marijuana (Cannabis) | This condition involves the ingestion of marijuana (cannabis) with a low THC (<1%) and high CBD (>10%) content. Cannabis: 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. |
| OG002 | No THC/No CBD | This condition involves the ingestion of a placebo control with no THC and no CBD content. Placebo: Placebo control group, not receiving THC or CBD. |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | High CBD/Low THC Cannabis | Adverse events after receiving Low THC (<1%)/High CBD (5-10%) cannabis | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Placebo Cannabis | Adverse events after receiving placebo (0% THC/ 0% CBD) cannabis | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
|
| Minute 40 |
|
| Minute 60 |
|
| Minute 90 |
|
| Minute 120 |
|
| Minute 180 |
|
Test for main effect of time |
| Linear mixed effects regression |
F=7.00, df=6,10 |
| <.001 |
| Other |
A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction. |
| Test for main effect of condition | Linear mixed effects regression | F=6.26, df=2, 10 | .002 | Other | A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction. |