Phase 2 Multicenter Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of Inhaled Cannabis in Veterans for Treatment of Posttraumatic Stress Disorder (PTSD)
Multidisciplinary Association for Psychedelic Studies
Summary
The rationale for the use of inhalational cannabis to potentially treat PTSD symptoms is based on the many reports of cannabis attenuating PTSD symptom expression among individuals with PTSD, including veterans. Study MJP2 is intended to build off MJP-1 through use of a larger sample size, a parallel study design, and subjective bias mitigation methods to re-examine the use of inhaled high THC-containing cannabis versus placebo for management of PTSD symptoms in a U.S. Veteran sample. Together these studies are intended to provide valuable insights on the already widespread use of cannabis in individuals with PTSD, for which there is currently a lack of controlled evidence available reflective of this real-world use.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be at least 18 years old. 2. Be a veteran with PTSD lasting 6 months in duration. 3. Meet DSM-5 criteria for PTSD with symptoms (as assessed by the MINI). 4. Have PTSD of at least moderate severity (PCL-5 score of 33 or more) at the time of screening. 5. For participants assigned female sex at birth: a) A participant is eligible to participate if not pregnant, and one of the following conditions applies: i) Is not able to become pregnant as defined in protocol (Appendix 2) OR ii) Is a person able to be pregnant (PABP) and using a contraceptive method that is highly…
Interventions
- DrugHigh THC Cannabis
dried flower of the Cannabis sativa or indica plant with high (18-22%) THC content
- DrugPlacebo cannabis
Placebo contains \<1% THC
Location
- Scottsdale Research InstituteCave Creek, Arizona