FDA Approves Study of Ecstasy in Post Traumatic Stress Disorder

Press Release November 6, 2001
Media Contact

Tony Newman at 510-208-7711 x 1383 or Shayna Samuels at 212-547-6916

On Friday, November 2, the Food and Drug Administration approved the first clinical trial of Ecstasy (also known by its chemical name, MDMA) as a treatment for Post Traumatic Stress Disorder (PTSD). The study, to be conducted by Dr. Michael Mithoefer, is now awaiting approval from the research review board at The Medical University of South Carolina in Charleston.

This marks the first time the FDA has sanctioned a study exploring the potential of MDMA to treat a psychiatric disorder. Despite millions of illicit Ecstasy tablets consumed in this country, only three research groups have received permission to give MDMA to human subjects. “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 Dr. 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 protocol outlines 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 twenty subjects who have PTSD as a result of crime victimization, including childhood sexual or physical abuse. The effects of 125 mg. of MDMA delivered within a controlled therapeutic setting to patients with chronic PTSD will be compared with placebo administered in otherwise identical sessions.

In the 1970s and 1980s, MDMA was used primarily by psychiatrists to help achieve breakthroughs in therapy. These same physicians sued the Drug Enforcement Administration when it filed motions in the Summer of 1984 to place the drug in the most restrictive category of controlled substances, Schedule I. Although the court proceedings resulted in a recommendation from the administrative law judge that the drug be placed in Schedule III, where clinical research could continue, the DEA opted to place MDMA in Schedule I, implying it had no medicinal value and a high potential for abuse. Since the Summer of 1985 when MDMA was placed in Schedule I, clinical research has been nearly impossible to perform while illicit use has gone largely unchecked. In the past five years, Ecstasy use has doubled among young people: eleven percent of American high school seniors and over thirteen percent of college students now report they have tried the drug.

“People are using Ecstasy in an unsafe manner and need to be educated about its risks,” says Bellevue attending psychiatrist Dr. Julie Holland. “But being a popular illicit drug does not negate the potential medical benefits. There is strong anecdotal evidence that MDMA-assisted psychotherapy sessions, performed prior to the drug’s scheduling, achieved real gains in patients with PTSD. MDMA provides an opportunity to process a trauma in a more comfortable atmosphere–similar to anesthesia which allows painful surgery to proceed.”

Dr. Holland, Clinical Assistant Professor of Psychiatry at New York University School of Medicine, has compiled the opinions of twenty-two of the world’s leading experts in the first comprehensive and authoritative book on MDMA. The Charleston protocol, and similar studies, are discussed in the newly released Ecstasy: The Complete Guide. A Comprehensive Look at the Risks and Benefits of MDMA, which details the history of MDMA-assisted psychotherapy, and explores the use of MDMA to treat psychiatric and medical conditions. This book also conducts a thorough review of the risks of Ecstasy use, and all current clinical MDMA research worldwide.

“MDMA is a unique compound with great potential for positive use. This is the most complete book about it, with much information to help people realize that potential as well as reduce any possible harm.” –Andrew Weil, M.D.

Promotional copies are available from: Jody Winters, Publicist, Inner Traditions/Bear & Co. [email protected].
phone (505)982-3660
fax (505)989-8311

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