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 — DRUG
    Cannabis consisting of 2.5mg CBD and 0mg Delta-9-tetrahydrocannabinol (THC) is administered via smoking.
  • Placebo only — DRUG
    Placebo 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 — DRUG
    Cannabis containing 2.5mg THC and 0mg CBD is administered via smoking.
  • THC:CBD 1:1 — DRUG
    Cannabis 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) only
    In 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) only
    In 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) only
    In 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 1:1
    In 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

Locations (1)

FacilityCityStateZIPSite coordinators
Tolan Park Medical BuildingDetroitMichigan48201
Leslie Lundahl, PhD
313-993-3964

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