Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery

Part of paid clinical trials in Detroit, Michigan.

Sponsor: Leslie Lundahl
Study ID: NCT06222268
Phase: PHASE1/PHASE2
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
Plant cannabis that will be smoked.
Placebo only — DRUG
Plant that will be smoked.
Delta-9-tetrahydrocannabinol (THC) only — DRUG
Plant cannabis that will be smoked.
THC:CBD 1:1 — DRUG
Plant cannabis that will be smoked.

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

First listed: Jan 24, 2024
Start date: Sep 30, 2026
Status verified: Aug 2026
Primary completion: Sep 30, 2031
Completion: Sep 30, 2031

Study Design

Enrollment: 280 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Placebo (PBO) Group
Cannabis with \<1mg THC and \<1mg CBD is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to this treatment arm. All participants will receive prolonged exposure therapy.
Experimental: Cannabidiol (CBD) only
Cannabis with 2.5mg CBD is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to this treatment arm. All participants will receive prolonged exposure therapy.
Experimental: Delta-9-tetrahydrocannabinol (THC) only
Cannabis with 2.5mg THC is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to this treatment arm. All participants will receive prolonged exposure therapy.
Experimental: THC:CBD 1:1
Cannabis with 2.5mg THC and 2.5mg CBD is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to this treatment arm. All participants will receive prolonged exposure therapy.