Trial Outcomes & Findings for Effects of Marijuana on Symptoms of OCD (NCT NCT03274440)
NCT ID: NCT03274440
Last Updated: 2020-11-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome 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.
Results posted on
2020-11-18
Participant Flow
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
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
4
|
1
|
1
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
4
|
0
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Time commitment too great
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Marijuana on Symptoms of OCD
Baseline characteristics by cohort
| Measure |
All Participants
n=12 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.
|
|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Psychiatric Comorbidity
Major Depressive Disorder (MDD)
|
2 Participants
n=5 Participants
|
|
Psychiatric Comorbidity
Generalized Anxiety Disorder (GAD)
|
2 Participants
n=5 Participants
|
|
Psychiatric Comorbidity
Panic Disorder
|
1 Participants
n=5 Participants
|
|
Psychiatric Comorbidity
None
|
8 Participants
n=5 Participants
|
|
Medication Status
Selective Serotonin Reuptake Inhibitor (SSRI)
|
2 Participants
n=5 Participants
|
|
Medication Status
Unmedicated
|
10 Participants
n=5 Participants
|
|
Cannabis use at time of enrollment
|
3.8 days per week
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
|
20.1 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Speilberger State-Trait Anxiety Scale, Trait Version (STAI-T)
|
48.5 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Hamilton Depression Rating Scale, 17-Item (HDRS-17)
|
4.9 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
PRIMARY outcome
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.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).
Outcome measures
| Measure |
High THC/Low CBD Marijuana (Cannabis)
n=12 Participants
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.
|
Low THC/High CBD Marijuana (Cannabis)
n=12 Participants
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.
|
No THC/No CBD
n=12 Participants
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.
|
|---|---|---|---|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 0 (baseline)
|
17.45 score on a scale
Standard Deviation 7.46
|
17.00 score on a scale
Standard Deviation 8.07
|
17.09 score on a scale
Standard Deviation 4.16
|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 20
|
13.36 score on a scale
Standard Deviation 10.15
|
11.55 score on a scale
Standard Deviation 9.46
|
10.91 score on a scale
Standard Deviation 3.70
|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 40
|
11.09 score on a scale
Standard Deviation 6.82
|
11.64 score on a scale
Standard Deviation 9.91
|
9.00 score on a scale
Standard Deviation 2.59
|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 60
|
10.18 score on a scale
Standard Deviation 5.90
|
11.18 score on a scale
Standard Deviation 10.15
|
9.27 score on a scale
Standard Deviation 3.69
|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 90
|
9.00 score on a scale
Standard Deviation 4.80
|
9.91 score on a scale
Standard Deviation 7.62
|
12.18 score on a scale
Standard Deviation 7.44
|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 120
|
9.00 score on a scale
Standard Deviation 5.44
|
9.64 score on a scale
Standard Deviation 5.89
|
11.09 score on a scale
Standard Deviation 6.80
|
|
Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
Minute 180
|
10.18 score on a scale
Standard Deviation 6.35
|
11.64 score on a scale
Standard Deviation 10.12
|
10.00 score on a scale
Standard Deviation 4.77
|
SECONDARY outcome
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.A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).
Outcome measures
| Measure |
High THC/Low CBD Marijuana (Cannabis)
n=12 Participants
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.
|
Low THC/High CBD Marijuana (Cannabis)
n=12 Participants
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.
|
No THC/No CBD
n=12 Participants
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.
|
|---|---|---|---|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 0 (baseline)
|
44.18 score on a scale
Standard Deviation 15.37
|
45.00 score on a scale
Standard Deviation 14.30
|
42.27 score on a scale
Standard Deviation 10.87
|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 20
|
40.00 score on a scale
Standard Deviation 21.37
|
37.55 score on a scale
Standard Deviation 15.28
|
29.73 score on a scale
Standard Deviation 7.64
|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 40
|
36.00 score on a scale
Standard Deviation 13.54
|
36.00 score on a scale
Standard Deviation 15.63
|
29.36 score on a scale
Standard Deviation 7.37
|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 60
|
33.00 score on a scale
Standard Deviation 10.49
|
36.82 score on a scale
Standard Deviation 14.83
|
32.27 score on a scale
Standard Deviation 9.77
|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 90
|
34.91 score on a scale
Standard Deviation 11.48
|
34.64 score on a scale
Standard Deviation 10.56
|
35.91 score on a scale
Standard Deviation 10.17
|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 120
|
35.09 score on a scale
Standard Deviation 12.47
|
35.18 score on a scale
Standard Deviation 8.67
|
34.09 score on a scale
Standard Deviation 9.74
|
|
Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
Minute 180
|
35.18 score on a scale
Standard Deviation 10.65
|
37.45 score on a scale
Standard Deviation 15.64
|
32.45 score on a scale
Standard Deviation 9.27
|
Adverse Events
High THC/Low CBD Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High CBD/Low THC Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Reilly Kayser
Columbia University/New York State Psychiatric Institute
Phone: 6467748118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place