Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery
Part of paid clinical trials in Detroit, Michigan.
- Sponsor
- Wayne State University
- Study ID
- NCT06222268
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cannabidiol (CBD) only — DRUGCannabis consisting of 2.5mg CBD and 0mg Delta-9-tetrahydrocannabinol (THC) is administered via smoking.
- Placebo only — DRUGPlacebo is administered via smoking in the same way as active drugs. Placebo cannabis material obtained through National Institute of Drug Abuse (NIDA) contains 0mg THC and 0mg CBD
- Delta-9-tetrahydrocannabinol (THC) only — DRUGCannabis containing 2.5mg THC and 0mg CBD is administered via smoking.
- THC:CBD 1:1 — DRUGCannabis containing 2.5mg of THC and 2.5mg of CBD is administered via smoking.
Study Details
The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and/or suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.
Key Dates
- Start date
- Mar 31, 2026
- Status verified
- Jan 2026
- Primary completion
- Sep 30, 2031
- Completion
- Sep 30, 2031
Study Design
- Enrollment
- 280 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Placebo Comparator: Placebo (PBO) onlyIn a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
- Experimental: Cannabidiol (CBD) onlyIn a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
- Experimental: Delta-9-tetrahydrocannabinol (THC) onlyIn a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
- Experimental: THC:CBD 1:1In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
Primary Outcome Measure
Treatment Response [ Time Frame: Through study completion, an average of 12 months ]
Central Contacts
- Paula Qefaliaj(313) 993-1374
- Leslie Lundahl, PhD(313) 993-1374
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tolan Park Medical Building | Detroit | Michigan | 48201 |
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