GROUP SAYS FDA CLEARS STUDY OF ECSTASY

WASHINGTON (Reuters) - A group that advocates the therapeutic use of
psychedelic drugs said on Wednesday it had secured federal approval
for the first study of Ecstasy, an amphetamine outlawed since 1985,
as a treatment for post-traumatic stress disorder.

But the most likely site for such a study, the Medical University of
South Carolina, said no decision had been made on whether to approve
the research.

"FDA officials ... informed me that the protocol was approved," said
Rick Doblin, president and founder of the Multidisciplinary
Association for Psychedelic Studies, in a statement.

The association, known by the acronym MAPS, has been trying for 16
years to win FDA permission to study Ecstasy as a psychotherapeutic
agent. The organization hopes to develop Ecstasy into a prescription
drug.

A spokeswoman for the Food and Drug Administration said she could not
confirm or deny whether the agency had signed off on the trial,
citing confidentiality rules.

Ecstasy, also known as MDMA, is an amphetamine that has both
stimulant and hallucinogenic effects in humans. The drug is popular
among adolescents and young adults who attend "rave" dance parties,
clubs and rock concerts.

According to a Department of Justice Web site
(http://www.usdoj.gov/dea/concern/mdma/mdmaindex.htm), Ecstasy is not
as widely available as some other drugs, but its use has increased
significantly in the past decade.

The United States made Ecstasy illegal for medical or other uses in 1985.

Before that, many psychiatrists used MDMA in conjunction with
psychotherapy, Doblin, who has a doctorate in public policy from
Harvard, told Reuters.

The drug could help people with post-traumatic stress because it
enabled them to let go of fear and emotionally work through an
upsetting experience, he said.

"One of the main actions of MDMA is to help people deal with and
integrate fear ... it reduces the fear response."

An institutional review board at the Medical University of South
Carolina, where the planned study would take place, must still
approve the research before it can begin.

"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 campus, a university statement said. No decision was
expected before January at the earliest.

In the proposed MAPS study, 12 patients would receive MDMA therapy in
addition to psychotherapy. Eight patients would get a placebo and
psychotherapy.

The patients in the MDMA group would receive the drug twice at
sessions three to five weeks apart. Doblin said patients would be
given the drug in a hospital and remain there overnight.

The study would only enroll patients who had not overcome their
post-traumatic stress with previous psychotherapy and treatment with
an antidepressant, he said.

Experts say as many as 8 percent of Americans experience
post-traumatic stress disorder at some point in their lives.

Symptoms last longer than the depression or short-term stress that
occurs after traumatic events. Patients can experience nightmares and
flashbacks, feel emotionally numb or become irritable and easily
startled.

The disorder can strike after military combat, rapes, domestic abuse
or serious accidents. Some experts predict it will also affect many
Americans trying to cope with the Sept. 11 attacks.