Study of the Safety and Efficacy of Smoked Marijuana in Veterans with Posttraumatic Stress Disorder (PTSD)

This study is sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a U.S.-based. MAPS sponsors clinical research evaluating the potential of psychedelics and marijuana to become FDA-approved prescription medicines.  This study will continue MAPS’ investigation into the treatment of PTSD with the first randomized controlled trial (RCT) to test the therapeutic potential of smoked marijuana and its components as a treatment for PTSD. This study is essential for understanding potential risks and therapeutic benefits of marijuana for PTSD patients. MAPS is seeking to conduct the marijuana/PTSD pilot study described in this protocol in response to many reports of marijuana attenuating PTSD symptom expression among individuals with PTSD, including veterans PTSD.

This pilot study will gather preliminary evidence of the safety and efficacy of four potencies of smoked marijuana to manage PTSD among veterans. By working with veterans, we address a national emergency and limit variability at the potential expense of generalizability. Further research will be needed to determine if these results will apply to other groups of PTSD sufferers. Smoked marijuana will be tested in two stages of three weeks each (Stage 1 and Stage 2), with a two-week cessation after each stage, verified by urine cannabinoid analysis. The study will produce preliminary evidence to help elucidate the contribution of THC, CBD, or a combination of both constituents to potential attenuation of PTSD symptoms. This study is critically important for understanding the potential risks and benefits of marijuana as a treatment for PTSD and can inform the development of larger randomized controlled clinical trials. Results will provide information regarding marijuana dosing, composition, side effects, and specific areas of benefit to clinicians and legislators considering marijuana as an acceptable treatment for PTSD. This study will also provide information on the predictive value and/or assessment of the impact of marijuana on selected biomarkers of inflammation, and effects of marijuana concentration upon these biomarkers as a measure of PTSD treatment response.