Newsbrief:
MAPS-Sponsored
Ecstasy
Research
Wins
Final
FDA
Approval
9/26/03
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced Tuesday that its groundbreaking study on the therapeutic use of MDMA (ecstasy) in treating Post Traumatic Stress Disorder has conquered the penultimate government hurdle. The Institutional Review Board reviewing the proposed research granted final approval Tuesday, after nearly two years of allowing it to languish. The Institutional Review Board decision is required under Food and Drug Administration (FDA) guidelines. The FDA approved the study in November 2001. MAPS noted that it took eight separate applications before various IRBs before succeeding this week. Now, the proposed study lacks only the issuance of a DEA Schedule I license for researcher Dr. Michael Mithoefer. MAPS applied for that license 15 months ago. "We hope to receive a license somewhat quickly now that IRB approval has been obtained, but you can never tell with DEA," the group noted. Once that license has been granted, the research can begin. Researchers in the 1980s began research into MDMA's therapeutic effects on a number of disorders, but that research was squelched when MDMA was reclassified as a Schedule I substance in 1986 after partiers in Texas were observed having way too much fun with it. MAPS has been instrumental in attempting to get research into the drug's therapeutic uses going in, and has even crafted a "5-year Clinical Plan to make MDMA into a prescription medicine for the treatment of post-traumatic stress disorder." For more information, visit the MDMA research pages at MAPS, http://www.maps.org/research/mdma/.
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