FDA CLEARS FIRST STUDY ON ECSTASY

Much-Abused Recreational Drug Would Be Tested On Post-Traumatic Stress
Disorder Victims

The U.S. Food and Drug Administration has approved the use of the illegal
and controversial drug Ecstasy in a study to treat victims of
post-traumatic stress disorder, a condition affecting some survivors of the
World Trade Center attack.

The approval, the first for therapeutic use of a drug that has been illegal
since 1985, was both hailed as a breakthrough by those who believe it can
help those suffering from PTSD and mental disorders, and denounced by other
scientists and doctors who feel Ecstasy could exacerbate the condition and
give a false sense of security to millions who use the drug recreationally.

"Ecstasy can play a major role in the psychiatry of the future," said Rick
Doblin, the president of the Multidisciplinary Association for Psychedelic
Studies, a nonprofit group that is sponsoring the study.

World Trade Center survivors will not be used in the study, but Doblin
hopes Ecstasy, or methylenedioxymethamphetamine (MDMA), will someday be
available as a prescription medicine and used to treat victims of the
terror attack. In the future, he said, it may also be used as a preventive
measure immediately after a traumatic event like Sept. 11.

But some psychiatrists and other experts dismiss the possibility of
benefits from a street drug whose use is skyrocketing among teenagers and
young people.

Glen Hanson, director of the division of neuroscience and behavioral
research for the National Institute on Drug Abuse, believes MDMA's
potential for good is overshadowed by its risks. He worries that approval
as a prescription medication, as its supporters hope, would give a false
sense of safety to those who use the drug illegally.

Many studies point to a strong correlation between heavy Ecstasy use and
loss of memory and other cognitive function.

"You have to play the benefit risk game. This is not a trivial, innocuous
drug," he said.

MDMA, a combination of amphetamine ("speed") and a mild hallucinogen,
stimulates brain neurons to release floods of serotonin, the
neurotransmitter that promotes a sense of physical and mental well-being.
Feelings of anxiety and inadequacy disappear, and the user feels a deep
sense of self acceptance, empathy and trust. Those feelings account for its
popularity as a street and nightclub drug.

Those same qualities can also enable a psychiatric patient to drop strong
defense mechanisms and talk about the core experience that is causing his
or her symptoms, an important component in recovery, according to
psychiatrists like Michael Mithoefer, a professor at the Medical University
of South Carolina in Charleston, who would conduct the research.

The study's next step is approval by the university's Institutional Review
Board, said Doblin, whose group is spearheading a $5 million, 5-year
campaign to bring the drug to market. The board will consider the study
protocol in January. If it moves ahead, it would be only the third
FDA-approved study of Ecstasy in the country (the other two were to
determine its safe use in humans), and one of a handful going on or planned
throughout the world.

The study would include 20 subjects who developed PTSD due to crime
victimization, including childhood sexual or physical abuse. They must be
diagnosed for at least six months and have failed to respond to
antidepressants like Zoloft, the current treatment drug of choice. Twelve
of the 20 would take MDMA, while the others would get placebos.

The MDMA would be administered in two separate doses of 125 mg, during two
therapy sessions in which the subjects would be encouraged to talk about
their trauma.

PTSD is triggered by a past traumatic experience like sexual assault, war,
childhood abuse or acts of terrorism. Symptoms include flashbacks,
generalized anxiety and panic attacks and avoiding places associated with
the trauma. Being able to deal with the triggering experience can help
alleviate those symptoms, said Julie Holland, a New York psychiatrist and
editor of "Ecstasy: The Complete Guide."

But Matthew J. Friedman, director of the National Center for Post Traumatic
Stress Disorder, cautions that the amphetamine in MDMA could actually set
off symptoms like panic attacks, since those who suffer from the disorder
are sensitive to stimulation.

"That would make me unwilling to use a drug like MDMA because it would
exacerbate a brain system that is already functioning abnormally. It's much
more likely to produce panic attacks, paranoia and other kinds of
abnormality. It wouldn't be on my list. I'd be afraid to try it," said
Friedman, a professor of psychiatry and pharmacology at Dartmouth Medical
School in New Hampshire.