At a glance
ClinicalIndex Comparison Record- ✓Military veteran with chronic, treatment-resistant PTSD of at least 6 months duration and at least moderate severity at baseline
- ✓At least 18 years old
- ✓Stable on pre-study PTSD medications and/or psychotherapy for the duration of baseline period and able to maintain stability during study participation
- ✓Willing to abstain from non-study cannabis for entire duration including 2-week baseline period (verified by urine/blood cannabinoid testing)
- ✕Current or past medical or psychiatric diagnosis that would create risk to study participation
- ✕Allergies to cannabis or contraindication for smoking cannabis
- ✕Current abuse of illegal drugs
- ✕Unable to provide adequate informed consent or attend face-to-face visits or planning to move out of area during treatment period
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating High THC cannabis, High CBD cannabis, and 2 other interventions for Posttraumatic Stress Disorder. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
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.