ECOS: Effects of Marijuana on Symptoms of OCD

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03274440
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 3
• Actual Duration (Months): 36.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Drug: Cannabis; Other: Placebo	Phase 1/Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Oct 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High THC/Low CBD Marijuana This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content.	Drug: 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.; Other Names: marijuana
Experimental: Low THC/High CBD Marijuana This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.	Drug: 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.; Other Names: marijuana
Placebo Comparator: No THC/No CBD This condition involves the ingestion of a placebo control with no THC and no CBD content.	Other: Placebo; Placebo control group, not receiving THC or CBD.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: Reilly Kayser, M.D., New York State Psychiatric Institute

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - May 10, 2018

More Information

Publications

None provided.

• Responsible Party: Reilly R. Kayser, Resident, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT03274440
• Other Study ID Numbers: # 7405
• First Posted: Sep 7, 2017
• Last Update Posted: Nov 18, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Reilly R. Kayser, Resident, New York State Psychiatric Institute: OCD; Marijuana; THC; Cannabis; CBD; Cannabinoid
• Additional relevant MeSH terms: Marijuana Abuse; Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Study Results

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 Detail	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.

Arm/Group Title	Order A	Order B	Order C	Order D	Order E	Order F
Arm/Group Description	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.	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	3	2	4	1	1	3
COMPLETED	2	2	4	0	1	3
NOT COMPLETED	1	0	0	1	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	In this within-subjects study, all participants received all three study drugs in random order. Demographic data is provided for all study participants together.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.8 (7.4)
Sex: Female, Male (Count of Participants)
Female	4 33.3%
Male	8 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%
Not Hispanic or Latino	10 83.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 8.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 16.7%
White	9 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Psychiatric Comorbidity (Count of Participants)
Major Depressive Disorder (MDD)	2 16.7%
Generalized Anxiety Disorder (GAD)	2 16.7%
Panic Disorder	1 8.3%
None	8 66.7%
Medication Status (Count of Participants)
Selective Serotonin Reuptake Inhibitor (SSRI)	2 16.7%
Unmedicated	10 83.3%
Cannabis use at time of enrollment (days per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days per week]	3.8 (2.9)
Yale-Brown Obsessive-Compulsive Scale (YBOCS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.1 (4.9)
Speilberger State-Trait Anxiety Scale, Trait Version (STAI-T) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	48.5 (13.9)
Hamilton Depression Rating Scale, 17-Item (HDRS-17) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.9 (4.7)

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High THC/Low CBD Marijuana (Cannabis)	Low THC/High CBD Marijuana (Cannabis)	No THC/No CBD
Arm/Group Description	This condition involves the ingestion of marijuana (cannabis) with a high THC (5-10%) and low CBD (<1%) 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.	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.	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.
Measure Participants	12	12	12
Minute 0 (baseline)	17.45 (7.46)	17.00 (8.07)	17.09 (4.16)
Minute 20	13.36 (10.15)	11.55 (9.46)	10.91 (3.70)
Minute 40	11.09 (6.82)	11.64 (9.91)	9.00 (2.59)
Minute 60	10.18 (5.90)	11.18 (10.15)	9.27 (3.69)
Minute 90	9.00 (4.80)	9.91 (7.62)	12.18 (7.44)
Minute 120	9.00 (5.44)	9.64 (5.89)	11.09 (6.80)
Minute 180	10.18 (6.35)	11.64 (10.12)	10.00 (4.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High THC/Low CBD Marijuana (Cannabis), Low THC/High CBD Marijuana (Cannabis), No THC/No CBD
	Comments	Test for interaction effect between condition and time (includes all three groups and all time points)
	Type of Statistical Test	Other
	Comments	A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.
Statistical Test of Hypothesis	p-Value	.577
	Comments
	Method	Linear mixed effects regression
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	High THC/Low CBD Marijuana (Cannabis), Low THC/High CBD Marijuana (Cannabis), No THC/No CBD
	Comments	Test for main effect of time (includes all three groups and all time points)
	Type of Statistical Test	Other
	Comments	A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Linear mixed effects regression
	Comments	F=10.50; df=6, 10

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	High THC/Low CBD Marijuana (Cannabis), Low THC/High CBD Marijuana (Cannabis), No THC/No CBD
	Comments	Test for main effect of condition (includes all three groups and all time points)
	Type of Statistical Test	Other
	Comments	A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.
Statistical Test of Hypothesis	p-Value	.72
	Comments
	Method	Linear mixed effects regression
	Comments

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High THC/Low CBD Marijuana (Cannabis)	Low THC/High CBD Marijuana (Cannabis)	No THC/No CBD
Arm/Group Description	This condition involves the ingestion of marijuana (cannabis) with a high THC (5-10%) and low CBD (<1%) 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.	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.	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.
Measure Participants	12	12	12
Minute 0 (baseline)	44.18 (15.37)	45.00 (14.30)	42.27 (10.87)
Minute 20	40.00 (21.37)	37.55 (15.28)	29.73 (7.64)
Minute 40	36.00 (13.54)	36.00 (15.63)	29.36 (7.37)
Minute 60	33.00 (10.49)	36.82 (14.83)	32.27 (9.77)
Minute 90	34.91 (11.48)	34.64 (10.56)	35.91 (10.17)
Minute 120	35.09 (12.47)	35.18 (8.67)	34.09 (9.74)
Minute 180	35.18 (10.65)	37.45 (15.64)	32.45 (9.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High THC/Low CBD Marijuana (Cannabis), Low THC/High CBD Marijuana (Cannabis), No THC/No CBD
	Comments	Test for interaction between condition and time
	Type of Statistical Test	Other
	Comments	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.
Statistical Test of Hypothesis	p-Value	.577
	Comments
	Method	Linear mixed effects regression
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	High THC/Low CBD Marijuana (Cannabis), Low THC/High CBD Marijuana (Cannabis), No THC/No CBD
	Comments	Test for main effect of time
	Type of Statistical Test	Other
	Comments	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.
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Linear mixed effects regression
	Comments	F=7.00, df=6,10

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	High THC/Low CBD Marijuana (Cannabis), Low THC/High CBD Marijuana (Cannabis), No THC/No CBD
	Comments	Test for main effect of condition
	Type of Statistical Test	Other
	Comments	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.
Statistical Test of Hypothesis	p-Value	.002
	Comments
	Method	Linear mixed effects regression
	Comments	F=6.26, df=2, 10

Adverse Events

Time Frame	Over the course of all 3 sessions, an average of 38 days.
Adverse Event Reporting Description	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
Arm/Group Title	High THC/Low CBD Cannabis		High CBD/Low THC Cannabis		Placebo Cannabis
Arm/Group Description	Adverse events after receiving High THC (5-10%)/Low CBD (<1%) cannabis		Adverse events after receiving Low THC (<1%)/High CBD (5-10%) cannabis		Adverse events after receiving placebo (0% THC/ 0% CBD) cannabis
All Cause Mortality
	High THC/Low CBD Cannabis		High CBD/Low THC Cannabis		Placebo Cannabis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)
Serious Adverse Events
	High THC/Low CBD Cannabis		High CBD/Low THC Cannabis		Placebo Cannabis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	High THC/Low CBD Cannabis		High CBD/Low THC Cannabis		Placebo Cannabis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.