Pubdate: Thu, 29 Jul 2004 Source: Charlotte Observer (NC) Copyright: 2004 The Charlotte Observer Contact: http://www.charlotte.com/mld/observer/ Details: http://www.mapinc.org/media/78 Author: David Kohn, Baltimore Sun Bookmark: http://www.mapinc.org/mdma.htm (Ecstasy) S.C. RESEARCHER SEEKS BENEFITS FROM ECSTASY Security measures required for federal approval of studies Somewhere in Charleston, in a safe bolted to the floor and protected by an alarm system, Michael Mithoefer keeps his supply of Ecstasy. The Drug Enforcement Administration ordered him to keep it secured in a secret place while he does the first U.S. trial of Ecstasy's therapeutic value. "You could probably go down to the local college campus and buy a lot more with a lot less trouble than breaking into the safe," he jokes. Mithoefer, a psychiatrist, is one of a handful of people in the United States allowed to do human research with Ecstasy, which the government puts in the same legal category as heroin. He is studying whether Ecstasy can help trauma victims heal their emotional wounds. The research has put him at the center of an intense debate over the drug's potential as a legitimate treatment. A small group of determined supporters -- including researchers and doctors at Harvard University and the University of California, Los Angeles -- have spent more than a decade fighting with the government and institutions for permission to do research. The DEA finally signed off a few months ago. Advocates say the drug could help treat a range of psychological problems. "I'd like to see it widely used in psychiatry," said Harvard psychiatrist John Halpern, a leading proponent. "It is potentially a very valuable tool." But some scientists and officials question the research, saying the drug has been proved to cause permanent harm to the brain, particularly to memory. "Let's not kid ourselves. The bulk of the evidence is on the side of risk," said David Murray, a policy analyst at the White House Office of National Drug Control Policy. "The only question is how permanent and how extensive the damage is." The controversy echoes the long-running dispute between advocates and the federal government over the use of marijuana for a range of ailments, including glaucoma and nausea. Although it has been illegal in the United States since 1985, Ecstasy, -- popularly called "X" or "E" -- is widely used as a recreational drug. More than 3 million Americans take it at least once a year, according to a 2002 government survey. Unlike heroin and cocaine, Ecstasy is not physically addictive. It has stimulant and hallucinogenic properties, and it generally gives users a sense of euphoria and contentment without impairing cognitive or motor abilities, as alcohol does. Ecstasy pills are produced in illegal laboratories in the United States and abroad. Mithoefer's source of the drug, whose chemical name is 3,4-Methylenedioxy-methamphetamine, or MDMA, is a government-licensed lab. Mithoefer, Halpern and others think the drug could particularly help people with post-traumatic stress disorder. Many patients can't bring themselves to talk about the painful events that triggered their problems. Ecstasy, the theory goes, could help people confront these traumas. "MDMA makes people comfortable with themselves. It brings them into the moment," said Rick Doblin, director of the Multidisciplinary Association for Psychedelic Studies, a nonprofit group funding Mithoefer's research. "With PTSD, people are trapped in the past." Although Doblin, 50, is not a doctor or a researcher, he has extensive experience with the drug, having taken it more than 100 times. "It's contributed enormously to my life," he said. Over the past 20 years, he has devoted himself to spreading the idea that Ecstasy and other hallucinogens have important medical benefits. The S.C. trial, which will cost $250,000, represents a milestone in his quest. If it goes well, Doblin hopes to fund larger national studies. His ultimate goal is persuading the Food and Drug Administration to approve MDMA as a prescription drug. Mithoefer's study involves 20 subjects: 12 will take the drug, and eight will receive a placebo. Patients will take it twice during a 12-week course of psychotherapy. After taking Ecstasy, patients spend eight hours talking to Mithoefer and another therapist, trying to work through especially difficult problems. Early results are promising, Mithoefer said, but the study won't be complete until next summer. Before the drug was criminalized, a few hundred psychiatrists and therapists around the country were using it. No controlled studies were done, but many who tried it say it worked. Between 1980 and 1985, Santa Fe, N.M., psychiatrist George Greer used the technique with about 200 patients. Greer said almost all thought it helped them. He finds it "incredibly frustrating" that he can't use the drug in his practice. "I see patients every day who could benefit," he said. Proponents of the therapy take pains to distinguish it from recreational use, which they see as potentially dangerous. Street users aren't in a controlled setting, they say, and often unknowingly take pills tainted with methamphetamine and other drugs. During the MDMA sessions in Mithoefer's trial, an emergency room doctor and a nurse are in the next room. The drug often raises body temperature and in rare cases causes fatal hyperthermia. What concerns some researchers more is that even a few doses of MDMA could cause permanent brain damage. Over the past decade, the question of Ecstasy's "neurotoxicity" has engendered enormous controversy. Some animal research has found that even small amounts of the drug harmed brain neurons that release serotonin, a key neurotransmitter involved in memory. In some studies, memory deficiencies persisted long after the drug was taken. And some human research on Ecstasy users has also found memory problems. "There's a consensus that MDMA has the ability to damage brain serotonin cells," said Johns Hopkins University neurologist George Ricaurte, a leading MDMA researcher. - --- MAP posted-by: Josh