Source: Washington Post (DC)
Author: Rick Weiss, Washington Post Staff Writer
Published: Tuesday, March 2, 2004; Page A02
Copyright: 2004 Washington Post
Contact: [email protected]
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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