The Drug Enforcement Adminsitration (DEA) has approved a study of MDMA (pure ecstasy) for the treatment of anxiety associated with terminal illnesses.
“On March 13, 2015, the U.S. Drug Enforcement Administration approved the Schedule I license for Phil Wolfson, M.D., the Principal Investigator for our upcoming study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness”, the Multidisciplinary Association for Psychedelic Studies (MAPS) said in a recent newsletter. “This was the final regulatory approval needed for the study, which was approved by an Institutional Review Board (IRB) on September 16, 2014, the Research Advisory Panel of California (RAPC) on December 15, 2014, and by the U.S. Food and Drug Administration on November 13, 2014.”
According to MAPS, the study, located in Marin, California, “will gather preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety in 18 subjects diagnosed with a life-threatening illness.”
“Obtaining DEA approval was the last step in the complex, arduous, and lengthy process of getting approval for our study,” says Dr. Wolfson.
The study is a randomized, double-blind, placebo-controlled Phase 2 study.