Ecstasy Heading for Clinical Trial
'Club drug' to be used in trauma test
WEDNESDAY, Nov. 14, 2001 (HealthDayNews) -- The FDA has given the go-ahead for the first-ever U.S. test of the controversial drug ecstasy as a possible treatment for post-traumatic stress disorder (PTSD).
Ecstasy heightens mood by releasing the "feel good" neurochemical serotonin in the brain. Use of the drug was criminalized in 1985 after its widespread use among young people was causing overdoses and other life-threatening incidents.
Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the study could begin as early as February 2002 at the Medical University of South Carolina in Charleston.
Researchers will study the effects of ecstasy, or MDMA, on people who suffered PTSD following a violent crime. PTSD often follows a high-stress or traumatic incident, including combat in war, a serious accident or some other seminal event.
In the study, 12 patients will receive two 125-mg. doses of the drug four weeks apart along with psychological counseling. There will also be a control group of eight patients who will receive placebos and counseling.
Despite the green light from the FDA, the researchers must await approval for the trial from the university's research review board and the Drug Enforcement Agency, which gives licenses for research involving controlled substances.
In a Nov. 7 statement, Medical University of South Carolina officials said, "Until such time that the board determines that the research meets ethical and legal standards, the protocol will not be tested on the Medical University of South Carolina campus."
Only one other clinical trial involving ecstasy is underway, and it's in Spain, where female victims of sexual assault are being treated. No results of that test are available yet.
For more information on why ecstasy is so dangerous, go to this site from the National Institutes of Health.