drugset / Trial / NCT02759185

Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

NCT02759185

RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2017-01-02
Primary completion
2018-11-01
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 1.8 g Other
Subject Dronabinol Other / unclassified 1.8 g Other
Subject THC/CBD cannabis Unknown 1.8 g Other