Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
1 other identifier
interventional
80
1 country
1
Brief Summary
This pilot study gathered preliminary evidence of the safety and efficacy of four potencies of smoked cannabis to manage chronic, treatment-resistant PTSD among veterans: (1) High THC/ Low CBD (High THC), (2) Low THC/High CBD (High CBD), (3) High THC/ High CBD (THC/CBD) and (4) Low THC/Low CBD (placebo). The study will produce preliminary evidence to help elucidate the potential effects of THC, CBD, or a combination of both constituents to reduce PTSD symptoms. Smoked cannabis will be tested in two stages of three weeks each (Stage 1 and Stage 2), with a two-week cessation period after each stage, verified by blood/urine cannabinoid analysis. The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Start
First participant enrolled
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedJuly 12, 2023
July 1, 2023
1.8 years
April 29, 2016
July 22, 2021
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Baseline CAPS-5 Total Severity Score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Baseline (3 weeks after randomization)
Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Visit 5 (between end of week 3 and start of week 4) of Stage 1
Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5)
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Baseline (3 weeks after randomization) to Primary Endpoint (Visit 5, between end of week 3 and start of week 4)
Secondary Outcomes (5)
Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint
Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint
Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint
Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint
Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint
Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Other Outcomes (1)
Actigraph Change in Sleep Efficiency
Change in sleep efficiency from baseline to end of 4-week treatment period (visit 6)
Study Arms (4)
High THC cannabis
EXPERIMENTALProvided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High CBD cannabis
EXPERIMENTALProvided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol
THC/CBD cannabis
EXPERIMENTALProvided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
Placebo cannabis
PLACEBO COMPARATORProvided 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Interventions
Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day.
Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day.
Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day.
Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day.
Eligibility Criteria
You may qualify if:
- Have chronic treatment-resistant PTSD of at least six months duration.
- Have PTSD of at least moderate severity at the time of baseline assessment.
- Be a military veteran with PTSD.
- Be at least 18 years old.
- Be willing to commit to medication dosing and delivery method, to completing evaluation instruments, and attending all study visits.
- Agree to use only cannabis provided by site staff and agree to required cessation periods for the duration of the study.
- Report no current hazardous cannabis use and completely abstain from cannabis during the 2-week baseline assessment period (verified via urine and/or blood cannabinoid concentrations).
- Agree to video record all cannabis administrations and provide video to the site staff for review during study participation.
- Agree to keep all cannabis provided by site staff securely stored in the provided lock box and not to share/distribute cannabis to any other individual.
- Be stable on any pre-study medications and/or psychotherapy regimen for PTSD prior to study entry, agree to notify their physician/clinician about participation in the study, and agree to report any changes in medication or psychotherapy treatment regimen during the study, to site staff.
- If female and of childbearing potential, agree to use an effective form of birth control during study participation and may only be allowed to enroll and continue in the study based on a negative pregnancy test.
- Be proficient in reading and writing in English and able to effectively communicate with site staff.
- Agree not to participate in any other interventional clinical trials during the study
You may not qualify if:
- Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.
- Have any allergies to cannabis or contraindication for smoking of cannabis
- Are abusing illegal drugs.
- Are not able to give adequate informed consent.
- Are not able to attend face-to-face visits or those who plan to move out of the area within the treatment period.
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scottsdale Research Institute
Phoenix, Arizona, 85027, United States
Related Publications (1)
Bonn-Miller MO, Sisley S, Riggs P, Yazar-Klosinski B, Wang JB, Loflin MJE, Shechet B, Hennigan C, Matthews R, Emerson A, Doblin R. The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial. PLoS One. 2021 Mar 17;16(3):e0246990. doi: 10.1371/journal.pone.0246990. eCollection 2021.
PMID: 33730032RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Berra Yazar-Klosinski, PhD / Chief Scientific Officer
- Organization
- Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Sisley, MD
President of Scottsdale Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2016
First Posted
May 3, 2016
Study Start
January 2, 2017
Primary Completion
November 1, 2018
Study Completion
January 1, 2019
Last Updated
July 12, 2023
Results First Posted
September 16, 2021
Record last verified: 2023-07