U.S. Veterans Study: DEA Approves Expanded Study Protocol
On August 22, 2012, the Drug Enforcement Administration approved Principal Investigator Michael Mithoefer, M.D.’s April 24 application to proceed with the amended study protocol for our ongoing study of MDMA-assisted psychotherapy for veterans, firefighters, and police officers with service-related PTSD, The amended protocol, which was cleared by the FDA and an Institutional Review Board in February 2012, expanded the study from 16 to 24 subjects and added the possibility of enrolling firefighters and police officers.
Ten subjects out of 24 have now enrolled in the study, and two more have passed screening. Seven have completed Stage 1. On August 31, the fourth subject completed their second experimental session in Stage 2 in our ongoing study of MDMA-assisted psychotherapy for veterans, firefighters, and police officers with service-related PTSD. This subject, who received an active placebo (30 mg) dose of MDMA in Stage 1 of the study, will complete one more open-label experimental psychotherapy session using a full (125 mg) dose of MDMA before entering the follow-up portion of the study.