Scientists in America are set to begin a controversial study to see if the dance-floor drug ecstasy could be used as a medicine to help people suffering from post-traumatic stress disorder.
In what will be the first trial of its kind, the researchers will 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 (FDA), 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 made illegal only 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 co-ordinating 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 in January, recruiting 20 victims of crime suffering from post-traumatic stress disorder who find it difficult to talk about their experience.
Each will receive 17 sessions of counselling with a therapist; before two sessions they will swallow a placebo or a capsule containing 125 milligrams of MDMA - more than the amount found in a typical ecstasy tablet. The trial will be double-blind, meaning neither the patients nor the investigators will know who has taken the drug. If the one-year trial is a success, further research will follow, Dr Doblin says.
Before considering ecstasy as a prescription drug for post-traumatic stress disorder, the FDA would require convincing evidence of its benefits from two larger studies using hundreds of people. The research is hugely controversial, and getting it off the ground has been difficult.
The FDA first approved the study in November 2001 but insisted that Dr Doblin's group also get the green light from an independent ethics review board. Permission was finally granted in September.
One hurdle remains. The Drug Enforcement Administration has not yet issued the licence needed to handle the 3.5 grams of ecstasy for the trial to the South Carolina psychiatrist who will administer it.
"My guess is that we'll get the approval before the end of the year," Dr 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 presents a false reassuring message about them.
Dr Doblin accepts that the drug carries risks, but insists they can be controlled.
- Guardian
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Ecstasy to be tested as treatment
By David Adam
London
November 25, 2003
Link
In what will be the first trial of its kind, the researchers will 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 (FDA), 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 made illegal only 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 co-ordinating 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 in January, recruiting 20 victims of crime suffering from post-traumatic stress disorder who find it difficult to talk about their experience.
Each will receive 17 sessions of counselling with a therapist; before two sessions they will swallow a placebo or a capsule containing 125 milligrams of MDMA - more than the amount found in a typical ecstasy tablet. The trial will be double-blind, meaning neither the patients nor the investigators will know who has taken the drug. If the one-year trial is a success, further research will follow, Dr Doblin says.
Before considering ecstasy as a prescription drug for post-traumatic stress disorder, the FDA would require convincing evidence of its benefits from two larger studies using hundreds of people. The research is hugely controversial, and getting it off the ground has been difficult.
The FDA first approved the study in November 2001 but insisted that Dr Doblin's group also get the green light from an independent ethics review board. Permission was finally granted in September.
One hurdle remains. The Drug Enforcement Administration has not yet issued the licence needed to handle the 3.5 grams of ecstasy for the trial to the South Carolina psychiatrist who will administer it.
"My guess is that we'll get the approval before the end of the year," Dr 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 presents a false reassuring message about them.
Dr Doblin accepts that the drug carries risks, but insists they can be controlled.
- Guardian
---------------------------
Ecstasy to be tested as treatment
By David Adam
London
November 25, 2003
Link
![[nl]mdma](/community/data/avatars/m/46/46037.jpg?1554214538){kind=avatar}
