Groundbreaking Cannabis PTSD Study Secures FDA Clearance

The Multidisciplinary Association for Psychedelic Studies (MAPS) has achieved FDA approval for its Phase 2 clinical trial, MJP2, after three years of negotiations and regulatory hurdles. This study will investigate the use of smoked cannabis in treating PTSD among 320 veterans across multiple states, aiming to generate real-world safety data. Funded by the Michigan Veteran Marijuana Research Grant Program, the trial uses cannabis with THC potencies reflective of products in legal markets.

Key milestones include overcoming FDA objections to the study’s design, such as self-titration dosing and smoking as a delivery method. However, the FDA still prohibits cannabis-naïve participants, citing safety concerns. MAPS’ persistence highlights its mission to challenge traditional regulatory frameworks and enable meaningful research on cannabis and psychedelics.

The study addresses the critical need for data on cannabis use for PTSD treatment, particularly for veterans. MAPS Founder Rick Doblin and Principal Investigator Dr. Sue Sisley emphasize the importance of new treatments for managing PTSD symptoms and preventing veteran suicides. This milestone sets a precedent for future cannabis research, offering hope for evidence-based solutions to life-threatening conditions.

Source: Yahoo Finance