Pubdate: Tue, 02 Mar 2004
Source: Washington Post (DC)
Page: A02
Copyright: 2004 The Washington Post Company
Author: Rick Weiss, Washington Post Staff Writer
Cited: Multidisciplinary Association for Psychedelic Studies
Bookmark: (Ecstasy)


Capping a 17-year effort by a small but committed group of activists,
the federal Drug Enforcement Administration has agreed to let a South
Carolina physician treat 12 trauma victims with the illegal street
drug ecstasy in what will be the first U.S.-approved study of the
recreational drug's therapeutic potential.

The DEA's move marks a historic turn for a drug that has long been
both venerated and vilified.

Ecstasy, also known as MDMA, is popular among casual drug users for
its reputed capacity to engender feelings of love, trust and
compassion. The government classifies it with LSD and heroin as a drug
with no known medical use and high potential for abuse.

Although the study's approval is by no means a federal endorsement of
uncontrolled use, it will give ecstasy's proponents their first
legitimate opportunity to prove the drug can offer medical benefits.

"MDMA opens the doorway for people to feel deep feelings of love and
empathy, which is the core of being human," said Rick Doblin,
president of the Multidisciplinary Association for Psychedelic Studies
in Sarasota, Fla., the nonprofit research and educational organization
funding the trauma study. "We should be looking at that and learning
from that."

As a result of the DEA action, sometime in the next few weeks the
study's first participant -- still to be selected -- will check in for
an overnight stay at an outpatient counseling center in the Charleston
area. (Investigators have asked that the location not be precisely
identified). He or she will take 125 milligrams of 99.87 percent pure
3,4-methylenedioxymethamphetamine -- probably the highest quality MDMA
on Earth -- synthesized by a Purdue University chemist.

Michael Mithoefer, the Charleston psychiatrist who will lead the
research, emphasized that ecstasy is by no means a benign drug.
Indeed, he said, on occasion it has proved deadly at all-night dance
parties, or raves, where it is often consumed.

"The fact that we have good evidence that we can use MDMA safely in a
controlled setting does not mean it is safe to take ecstasy at a
rave," Mithoefer said.

The goal is to help people with debilitating post-traumatic stress
disorder face the pain at the core of their illness, he said, and
learn to work with it.

"Because of MDMA's reported ability to decrease levels of fear and
defensiveness and increase the sense of trust, we hope that will be a
catalyst for the therapeutic process," Mithoefer said.

Advocates have been aiming for such a study since 1986. The Food and
Drug Administration gave its blessing in November 2001 after long
consideration and analysis of three human safety studies funded by
Doblin's group. It was two more years before the study got the
required approval of an independent science and ethics board.

The DEA's issuance last week of a Schedule 1 registration, which
allows Mithoefer to administer the drug under the specific conditions
of the study, was the last hurdle.

 From all indications, it was not a decision made lovingly by an
agency that has called ecstasy "one of the most significant emerging
drug threats facing America's youth." But with all the other federal
requirements met, the role of the DEA -- whose responsibility is to
prevent "diversions" of the drug -- was limited to documenting that
Mithoefer had a big enough safe bolted securely enough to the floor, a
qualifying alarm system and a set of records that would ensure careful
tracking of every speck of the stuff.

"Whether we agree with the study is not relevant," said Bill Grant,
the spokesman for the DEA. "All the qualifications were met."

Even some of ecstasy's leading critics said they could abide by the
study if regulators were satisfied.

"The key issue is that all potential subjects be fully informed of the
risks," George Ricaurte, a professor of neurology at Johns Hopkins
University who has studied the drug, wrote in an e-mail.

Ecstasy was popular more than 20 years ago as an aid to psychotherapy.
Recreational abuse drew it to the attention of the DEA, which in the
mid-1980s began regulating it.

A black market emerged, and millions of young ravers and others have
since tried the substance, which can induce what enthusiasts describe
as up to eight hours of empathic conversation, contemplation and
energetic sociality.

Most users report no long-term negative effects, though some speak of
fatigue or depression for a few days afterward. There is a heated
scientific debate as to whether ecstasy causes significant, long-term
damage to parts of the brain.

All experts agree that ecstasy on rare occasions causes a sudden,
inexplicable and fatal form of heat exhaustion. That is one reason
there will be an emergency room doctor and nurse outside the
Charleston-area therapy room -- where each patient will sit and talk
for hours with Mithoefer and his wife, psychiatric nurse Annie Mithoefer.

To be chosen for the study, the patients -- all victims of assaults
unrelated to combat -- must have moderate to severe post-traumatic
stress disorder unresponsive to other drugs and therapies, and will
first engage in preliminary therapy sessions with the Mithoefers.
Twelve participants will get the drug, and eight will get a placebo.
Each will spend that first session talking, listening to music and
lying on a couch as needed -- though study rules require that at a
certain point each patient must engage in a discussion about the
trauma that has left him or her debilitated.

Periodic physical, emotional and neurological checkups will continue
for several weeks, followed by a second ecstasy session.

Marcela Ot'alora, who in 1984 -- before ecstasy's use was criminalized
- -- took it under a therapist's supervision to help her deal with the
aftereffects of being raped, lauded the Charleston study's approval.

For years, she had been unable to wait in lines or stand with her back
to crowds because of a fear of being attacked, said Ot'alora, who
today is a therapist in a western state that she asked not be revealed.

Ecstasy had a profound effect, she said: "I think for the first time
in my life I was able to have compassion for myself, and also felt I
was strong enough to face something that was frightening without
falling apart.

"It's not a miracle drug, by any means," she continued. "But it allows
you to go into the trauma and know it is past, and separate it from
the present."

She said she has not wanted to take the drug again, even though she
still feels less than fully healed.

"It's almost like it showed me the path I needed to take," she said,
"and I can do that on my own now." 
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