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This is a story that ran on CNN 2/25/2004

Ecstasy approved for medical study

WASHINGTON (CNN) -- A South Carolina psychiatrist said Wednesday he will immediately start recruiting patients after winning approval to conduct the first study testing MDMA -- better known as ecstasy -- as a therapeutic tool.

Dr. Michael Mithoefer plans to conduct psychotherapy sessions with 20 women who suffer from post-traumatic stress disorder due to sexual assaults or other violence, and who haven't been helped by other treatment. Twelve of the women will receive MDMA prior to the sessions while eight will be given a placebo.

The Food and Drug Administration approved Mithoefer's protocol in 2001, but it took another two years to find an institutional review board willing to sanction the study, which is a required step when dealing with human research subjects.

Mithoefer's research required approval from the Drug Enforcement Administration because MDMA is a Schedule I drug. It's grouped with drugs like heroin, cocaine and LSD, all considered to have no medical use.

Bill Grant, a spokesman for the DEA, said the final approval came Tuesday night.

Mithoefer says he works with post-traumatic stress disorder patients all the time and he's excited about the possibility of finding a better treatment for the hundreds of thousands of Americans who suffer from the sometimes debilitating disorder.

"We owe it to them," he said. "It would be irresponsible for the medical community not to investigate something like this."

At the same time, he warns that using MDMA in an uncontrolled setting can be very dangerous.

"It's really important for people to realize the fact that we have permission to do this study and we can do it safely in this setting," he said.

Also, the fact that he's received permission for the study, he said, "does not mean that you can use ecstasy safely and anywhere."

MDMA was first invented in 1912 but largely ignored until young people made it a recreational drug starting in the late 1970s. Psychiatrists quickly became aware of its unusual properties, and several dozen experimented by giving MDMA to patients -- including people suffering post-traumatic stress disorder -- and others with intense anxiety after receiving diagnoses of terminal cancer.

One of those patients from the early 1980s is an artist now living in the western United States, who spoke with CNN. She did not want her name used.

After being raped and beaten at age 17, the woman suffered severe panic attacks for eight years, leading to three hospitalizations before being treated with MDMA. Before those sessions, she said her trauma was misdiagnosed as schizophrenia, severe depression and bipolar disorder.

"MDMA allowed me, for the first time, to sit with the details of the event, and separate them from what was happening in the present," she told CNN. "I was able to relax my body. I was able to say, 'this is not happening to you right now.' "

Suicidal at the time, she said the treatment may have saved her life.

"There might have been another way, but the way that I see it is that I probably would have died," she said.

"When someone is traumatized, walls form around trauma -- like a scar -- and it's hard to get someone to open up and talk about it," explains Dr. Julie Holland of New York University, author of "Ecstasy: A Complete Guide."

"What's unique about MDMA is that it's actually stimulating but decreases anxiety," Holland told CNN. "It could help people feel calm and comfortable enough to explore painful things that are hard to talk about."

"A good analogy is that it would give psychiatry something akin to anesthesia during therapy," she said. "And unlike anesthesia, your memory is completely intact, but even enhanced. You remember the trauma very clearly, but are comfortable enough to talk about it."

"Because it anesthetizes the patient to some extent," Holland said, "you can get to that malignant core in one or two sessions instead of three or four years."

But Dr. Scott Lillienfeld, a psychiatrist at Emory University who has studied post-traumatic stress disorder, said that hypothesis is "at the least, muddled."

Lillienfeld said effective treatment actually requires the patient to face their trauma head-on. "If you're calm, you're not getting at the root of the problem," said Lillienfeld.

He also said Mithoefer's study has methodological problems.

"There's no real placebo," he said. "Everyone will know who's on the drugs. What I wonder is, instead of a placebo, why aren't they giving a drug that mimics the physical effects?"

Mithoefer said all participants will have to undergo psychiatric screening and a physical exam to ensure they don't have any physical risk factors. Ecstasy, a strong stimulant, is thought to be particularly dangerous to people with high blood pressure. It also has been known to cause dangerous overheating in people who take it and then exercise or dance for a long period of time.

Patients in this clinical trial will be given the drug only one or two times. They will be under a doctor's supervision for the entire time they are under the drug's influence.

Mithoefer said he hopes to begin the actual therapy sessions next month.

CNN producers Caleb Hellerman and Miriam Falco contributed to this report.

This is a story that ran on Peter Jennings World News Tonight 4/1/2004

Ecstasy Rising

 

Federal Campaign to Curb Club Drug's Use Hasn't Dimmed Its Popularity

In the 1990s, Ecstasy seemed to come out of nowhere to join marijuana, cocaine and heroin as one of the four most widely used illegal drugs in the country. If current trends continue, 1.8 million Americans will try Ecstasy for the first time in 2004; only marijuana will attract more new users.According to Mark Kleiman, a drug policy analyst at the University of California, Los Angeles, this is a rare phenomenon. "Having a new, major drug arrive on the scene is something that happens every half-century or so," he told ABCNEWS. "This is a major event in drug history."So how did this happen? How did an obscure compound with the chemical name MDMA, and the street name Ecstasy, earn a place among the pantheon of major, illicit drugs?"After I used Ecstasy, I just felt like a whole new person, like it changed my life completely," said one user who preferred not to be named. "The drug makes you feel empathy, empathy for other people, empathy for situations," said another user who also didn't want his name used. "You just look at everything in the most positive light."

Good for You?

Overwhelming, positive word-of-mouth is often cited as the cause of Ecstasy's explosive growth."There is an evangelical fervor with Ecstasy," says Robert MacCoun, a drug policy analyst at the University of California, Berkeley. "People who experience it tell their friends to try it."This has never happened before, said Kleiman: "I have never heard anybody say to me methamphetamine improved my life. I know people who like to use cocaine, but I have never heard anybody try to claim that cocaine is good for me. But with MDMA, lots of people think that the drug has improved their life. "It was accounts such as this — that Ecstasy led to personal growth — that prompted psychotherapists to give the drug to their patients in the late 1970s, when it was still legal. But its strictly therapeutic use did not last long.In the early 1980s, Ecstasy became a wildly popular recreational drug in Dallas. After being made illegal in 1985, Ecstasy was temporarily pushed underground, but it soon resurfaced as the fuel of all-night dance parties called raves.

‘Government: Risks Are Real'

By the late 1990s, positive word of mouth had pushed Ecstasy far beyond the confines of the rave scene. Then the government decided to respond."My observation is that this drug has been particularly glorified in many different venues," says Alan Leshner, a former director of the National Institute on Drug Abuse, or NIDA. "In the course of that glorification, advocates for the drug have downplayed the risks associated to it. The risks are real."As the head of NIDA, Leshner launched the U.S. government's campaign against Ecstasy. The headline of this campaign is that Ecstasy causes massive brain damage.Whether this is true remains very controversial.The use of Ecstasy has declined among teenagers in the last two years. Is this an indication that Ecstasy is on the way out? Kleiman says no. "The propaganda effort has had its impact, but it competes rather poorly, though, with word of mouth. "And for this reason, Ecstasy will likely continue to spread and remain the drug of choice for a generation.