I like this - a famous classmate of mine is quoted. I get to name drop. It makes me feel gooood.
From the New Scientist:
quote:US approves first ecstasy trials for 16 years
18:45 07 November 01
Duncan Graham-Rowe
The US Food and Drug Administration has approved its first clinical study of Ecstasy since the drug was criminalised in 1985. The study will assess the drug, also known as MDMA, as a treatment for post-traumatic stress disorder.
Once the two month trial has been approved by the university review board, it will be carried out by a husband and wife team, Michael and Annie Mithoefer, at the Medical University of South Carolina.
In the 1970s, MDMA was used by psychiatrists to treat PTSD. It was believed to have a cathartic effect on patients, who have difficulty letting go of an emotional or stressful event.
"MDMA really helps reduce the fear response to a perceived emotional threat," says Rick Doblin, President of the Multidisciplinary Association for Psychedelic Studies, which is funding the study.
"This approval marks the culmination of 16 years of efforts to obtain permission from the FDA for MDMA-assisted psychotherapy research," he says. "It also marks the beginning of what I hope will be a $5 million, five-year project to develop MDMA into a prescription medicine."
Clinical setting
MDMA is currently being tested for PTSD in Spain and a group are applying for approval to test it in Israel. But the Spanish study involves only three test subjects, all of whom are women.
The new US study will look at both men and women who have already failed to respond to existing treatments for PTSD and who have not taken ecstasy before. A dozen people will be given the drug, with eight getting a placebo.
Doblin believes the reason for the change in attitude by the FDA is the growing evidence that MDMA is safe to use in a clinical setting. The FDA had been concerned about cardiovascular effects. Doblin adds that, during the two month trial, patients will only be given the drug twice.
But Alan Leshner, director of the US National Institute on Drug Abuse, says: "We normally don't give drugs of abuse to naive subjects. I hope great caution is being exercised."
18:45 07 November 01
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