Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02759185 |
Recruitment Status :
Completed
First Posted : May 3, 2016
Results First Posted : September 16, 2021
Last Update Posted : July 6, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Posttraumatic Stress Disorder |
Interventions |
Drug: High THC cannabis Drug: High CBD cannabis Drug: THC/CBD cannabis Drug: Placebo cannabis |
Enrollment | 80 |
Recruitment Details | Participants were recruited via letters of referral sent to psychiatrists and psychotherapists, contact with veterans' organizations, advertisements or announcements placed in appropriate locations or on appropriate internet sites and the sponsor site, and word of mouth. |
Pre-assignment Details | For Stage 2, participants were re-randomized into one of three treatment groups which excluded placebo and their Stage 1 treatment assignment. |
Arm/Group Title | High THC Cannabis (Stage 1) | High CBD Cannabis (Stage 1) | THC/CBD Cannabis (Stage 1) | Placebo Cannabis (Stage 1) | High THC Cannabis (Stage 2) | High CBD Cannabis (Stage 2) | THC/CBD Cannabis (Stage 2) |
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Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. |
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. |
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. |
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. |
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
Period Title: Stage 1 | |||||||
Started | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
Completed | 19 | 19 | 17 | 20 | 0 | 0 | 0 |
Not Completed | 1 | 1 | 3 | 0 | 0 | 0 | 0 |
Reason Not Completed | |||||||
Adverse Event | 0 | 1 | 3 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Stage 2 | |||||||
Started | 0 | 0 | 0 | 0 | 29 | 27 | 18 |
Completed | 0 | 0 | 0 | 0 | 27 | 24 | 17 |
Not Completed | 0 | 0 | 0 | 0 | 2 | 3 | 1 |
Reason Not Completed | |||||||
Adverse Event | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
Arm/Group Title | High THC Cannabis | High CBD Cannabis | High THC/ High CBD Cannabis | Placebo Cannabis | Total | |
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Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. |
Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. |
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol High THC/high CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day. |
Provided 1.8 g of cannabis per day a with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD, with smoking limited to no more than 1.8 per day. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 20 | 20 | 20 | 20 | 80 | |
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Intent-to-treat (ITT) set
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants | |
45.0 (16.6) | 40.4 (11.2) | 50.6 (13.3) | 43.7 (12.5) | 44.9 (13.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants | |
Female |
1 5.0%
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2 10.0%
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3 15.0%
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2 10.0%
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8 10.0%
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Male |
19 95.0%
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18 90.0%
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17 85.0%
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18 90.0%
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72 90.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race/Ethnicity | Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
Non-Hispanic White |
11 55.0%
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14 70.0%
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14 70.0%
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14 70.0%
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53 66.3%
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Other |
9 45.0%
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6 30.0%
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6 30.0%
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6 30.0%
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27 33.8%
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Education
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants | |
High School Graduate |
0 0.0%
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3 15.0%
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1 5.0%
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2 10.0%
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6 7.5%
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Some College/Associate's Degree |
13 65.0%
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10 50.0%
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8 40.0%
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11 55.0%
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42 52.5%
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College Graduate |
7 35.0%
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7 35.0%
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11 55.0%
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7 35.0%
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32 40.0%
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Body mass index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants | |
32.0 (8.9) | 31.3 (6.6) | 31.4 (7.4) | 33.1 (7.0) | 31.9 (7.4) | ||
Combat-related trauma (yes)
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants | |
13 65.0%
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13 65.0%
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15 75.0%
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13 65.0%
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54 67.5%
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Sleep Apnea (STOP-bang)
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
Low risk = 1 |
6 30.0%
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6 30.0%
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4 20.0%
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6 30.0%
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22 27.5%
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Intermediate risk = 2 |
3 15.0%
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3 15.0%
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3 15.0%
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3 15.0%
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12 15.0%
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High risk = 3 |
11 55.0%
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11 55.0%
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13 65.0%
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11 55.0%
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46 57.5%
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Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
[1] Mean (Standard Deviation) Unit of measure: Score on a scale |
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Number Analyzed | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants | |
3.9 (3.0) | 2.5 (2.8) | 2.4 (2.8) | 1.7 (2.6) | 2.6 (2.8) | ||
[1]
Measure Description: The CUDIT-R is a brief cannabis screening tool to identify cannabis misuse. Participants who report past six month cannabis use are asked eight additional questions on cannabis where each item score range from 0 to 4. The total CUDIT-R score ranges from 0 to 24 with ≥ 8 indicating hazardous cannabis use and ≥ 12 indicating a possible cannabis use disorder.
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Name/Title: | Julie B. Wang, MPH, PhD (Senior Clinical Data Scientist) |
Organization: | Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation |
Phone: | (831) 429-6362 |
EMail: | juliewang@mapsbcorp.com |
Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
ClinicalTrials.gov Identifier: | NCT02759185 |
Other Study ID Numbers: |
MJP-1 |
First Submitted: | April 29, 2016 |
First Posted: | May 3, 2016 |
Results First Submitted: | July 22, 2021 |
Results First Posted: | September 16, 2021 |
Last Update Posted: | July 6, 2022 |