Ecstasy approved for medical study
Wednesday, February 25, 2004 Posted: 11:06 PM EST (0406 GMT)
WASHINGTON (CNN) -- A South Carolina psychiatrist said Wednesday he will immediately start recruiting patients after winning approval to conduct the first study testing MDMA -- better known as ecstasy -- as a therapeutic tool.
Dr. Michael Mithoefer plans to conduct psychotherapy sessions with 20 women who suffer from post-traumatic stress disorder due to sexual assaults or other violence, and who haven't been helped by other treatment. Twelve of the women will receive MDMA prior to the sessions while eight will be given a placebo.
The Food and Drug Administration approved Mithoefer's protocol in 2001, but it took another two years to find an institutional review board willing to sanction the study, which is a required step when dealing with human research subjects.
Mithoefer's research required approval from the Drug Enforcement Administration because MDMA is a Schedule I drug. It's grouped with drugs like heroin, cocaine and LSD, all considered to have no medical use.
Bill Grant, a spokesman for the DEA, said the final approval came Tuesday night.
http://www.cnn.com/2004/HEALTH/02/25/ecstasy.study/index.html