FDA Reported to Approve Ecstasy for PTSD Clinical Trial

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FDA Reported to Approve Ecstasy for PTSD Clinical Trial



[Alcoholism & Drug Abuse Weekly 13(43):4, 2001. © 2001 Manisses Communications Group, Inc.]





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According to news reports from the Wall Street Journal and the Associated Press, the Food and Drug Administration (FDA) has approved an application by researchers affiliated with the Medical University of South Carolina to conduct a clinical trial using MDMA (Ecstasy) to treat post-traumatic stress disorder (PTSD). The university has not formally approved the clinical trial, however.



The approval of a trial using Ecstasy, a drug that has become widely abused among students and young adults, caught many in the addiction treatment field by surprise. Alan I. Leshner, Ph.D., director of the National Institute on Drug Abuse (NIDA), responded to the news by telling the Wall Street Journal, "I know of no evidence in the scientific literature that demonstrates the efficacy of Ecstasy for any clinical indication. We don't give drugs of abuse to naïve subjects except under extraordinary circumstances."



NIDA teamed up in 1999 with the American Academy of Child and Adolescent Psychiatry (AACAP), Community Anti-Drug Coalitions of America (CADCA), Join Together and National Families in Action to spearhead a club drug prevention effort, of which Ecstasy was a major target (see ADAW, Dec. 13, 1999). The multimedia campaign includes a Web site --<A HREF=http://www.clubdrugs.org TARGET=_blank>www.clubdrugs.org</A> -- and has distributed postcards in shopping malls throughout the country.



The clinical trial, if approved by the Medical University of South Carolina's institutional review board, would mark the first time the FDA has sanctioned Ecstasy to treat a psychiatric disorder. In a released statement, the university stated, "A research protocol involving the testing of the drug MDMA (Ecstasy) on human subjects has not come up for review by this board. Until such time that the board reviews and determines that the research meets ethical and legal standards, the protocol will not be tested on the Medical University of South Carolina campus."



Michael Mithoefer, M.D., upon university approval, will conduct the research. "Despite the serious problems that can occur with uncontrolled use, there is good evidence that MDMA can be used safely in a controlled clinical setting," said Mithoefer. "The potential benefits from research that could lead to better treatment for patients suffering from chronic PTSD outweigh the minimal toxicity potential from therapeutic doses of MDMA."



The clinical trial would be a double-blind, placebo-controlled study designed to investigate the safety and efficacy of two MDMA-assisted psychotherapy sessions conducted three to five weeks apart. Researchers will enroll 20 subjects who have PTSD as a result of crime victimization, including childhood sexual or physical abuse. The MDMA-assisted therapy will be compared with a placebo.



The study is being funded by the Multidisciplinary Association for Psychedelic Drugs (MAPS), a group whose goal is to make certain psychedelic drugs prescription medicine. According to MAPS, the effort to use MDMA in psychotherapy research has been under way since the FDA designated MDMA as a Schedule 1 drug in 1985. Prior to that, MDMA was used by some as part of PTSD therapy.



However, recent studies have raised concerns about Ecstasy's impact on the brain. A study published in the October issue of the Archives of General Psychiatry linked use of the drug to impaired memory function (see ADAW, Oct. 22). Ecstasy users showed brain neuron changes related to the neurotransmitter serotonin.



Other researchers have theorized that Ecstasy causes dramatic fluctuations in serotonin levels. Some believe that long-term use can cause lasting depression.



In addition, Ecstasy use rates among youths are decidedly on the rise. The latest Monitoring the Future survey found a sharp increase in use among 8th, 10 th and 12th graders.





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