Pubdate: Mon, 24 Nov 2003 Source: Guardian, The (UK) Copyright: 2003 Guardian Newspapers Limited Contact: http://www.guardian.co.uk/guardian/ Details: http://www.mapinc.org/media/175 Author: David Adam, science correspondent ECSTASY MAY BE USED TO HELP RAPE VICTIMS US Study To Look At Therapeutic Value Of Dancefloor Drug Scientists in America are set to begin a controversial study to see if the dancefloor drug ecstasy could be used as a medicine to help people suffering from post-traumatic stress disorder, the Guardian has learned. In what will be the first trial of its kind, the researchers want to see if the emotional closeness reported by clubbers taking the drug can help victims of rape and sexual abuse talk to therapists. Supporters of the study, which has been approved by the US Food and Drug Administration, claim it marks an important milestone in the medical rehabilitation of ecstasy or MDMA, which was given to patients by some alternative therapists in the 1970s and was only made illegal in the 1980s. "What we'd like to do is develop MDMA into a prescription medicine," said Rick Doblin, the founder and head of the Multidisciplinary Association for Psychedelic Studies, which is coordinating and funding the new trial. "MDMA has a dramatic ability to help people express deeper emotions, to look at emotionally conflicted topics from their past and it promotes a certain catharsis." The study could begin as soon as January. It will recruit 20 victims of crime suffering post-traumatic stress disorder (PTSD) who find it difficult to talk about their experience. Over several months, each will receive 17 sessions of counselling with a therapist; before two sessions they will swallow a capsule containing either a placebo or 125mg of MDMA - about the same as or a little more than the amount found in a typical ecstasy tablet. The trial will be double-blind, meaning that neither the patients nor the investigators will know who has taken the drug. If the one-year pilot study proves a success, Mr Doblin says further research will follow. Before considering ecstasy as a prescription drug for PTSD, the FDA would require convincing evidence of its benefits from two larger studies involving hundreds of people. The research is controversial, and getting it off the ground has proved difficult. The FDA originally approved the study in November 2001 but insisted that Mr Doblin's group also get the green light from an independent ethics review board. These oversee research and are usually attached to universities. Applications to seven different boards were all rejected because of fears of legal action, experimental bias, or in some cases with no explanation at all. Permission was only finally granted in September. One hurdle remains. The Drug Enforcement Administration has not yet issued the licence needed to handle the 3.5g of ecstasy for the trial to Michael Mithoefer, the South Carolina psychiatrist who will administer it. "My guess is that we'll get the approval before the end of the year," Mr Doblin said. The dangers of ecstasy remain uncertain. This year, scientists at Johns Hopkins School of Medicine were forced to admit that a high-profile discovery that just one dose of MDMA could cause irreversible brain damage and even death was nonsense because they had used the wrong drug in their experiment. But significant doubts remain over long-term risks: animal studies suggest that it can lower levels of the brain chemical serotonin and some anti-drugs campaigners and politicians have argued that research into the possible medical use of illegal drugs present a false reassuring messages about them. Mr Doblin accepts that the drug carries risks, but insists they can be controlled. "Of course there are risks, but I do believe the risks are manageable," he said. "We're excluding people with heart problems, excluding people with drug abuse problems and excluding people at major risk for suicide." The biggest threat could be how people react if the drug helps them unbottle fears and anxieties, he said, and so all volunteers will be closely supervised. Professor John Henry, a drugs researcher at St Mary's Hospital in London and one of Britain's leading experts on ecstasy, welcomed the research. "It's a question of context and control," he said. "So long as you use it for a very specific condition in controlled conditions as a scientist then I don't see any problem. I think it's good." - --- MAP posted-by: Keith Brilhart