FDA Approves Study of Ecstasy in Post Traumatic Stress
Disorder
On Friday, November 2, 2001 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. I am pleased that the FDA acknowledges this potential and is willing to go forward with clinical trials."