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