![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
symbioidljHooray MAPS!!!!!! You've done it again!
---------
WASHINGTON (Reuters) - A group that advocates the therapeutic use of psychedelic drugs said on Wednesday it had secured federal approval for the first study of Ecstasy, an amphetamine outlawed since 1985, as a treatment for post-traumatic stress disorder.
But the most likely site for such a study, the Medical University of South Carolina, said no decision had been made on whether to approve the research.
``FDA (news - web sites) officials ... informed me that the protocol was approved,'' said Rick Doblin, president and founder of the Multidisciplinary Association for Psychedelic Studies, in a statement.
The association, known by the acronym MAPS, has been trying for 16 years to win FDA permission to study Ecstasy as a psychotherapeutic agent. The organization hopes to develop Ecstasy into a prescription drug.
A spokeswoman for the Food and Drug Administration said she could not confirm or deny whether the agency had signed off on the trial, citing confidentiality rules.
Ecstasy, also known as MDMA, is an amphetamine that has both stimulant and hallucinogenic effects in humans. The drug is popular among adolescents and young adults who attend ``rave'' dance parties, clubs and rock concerts.
According to a Department of Justice (news - web sites) Web site (http://www.usdoj.gov/dea/concern/mdma/mdmaindex.htm), Ecstasy is not as widely available as some other drugs, but its use has increased significantly in the past decade.
The United States made Ecstasy illegal for medical or other uses in 1985.
Before that, many psychiatrists used MDMA in conjunction with psychotherapy, Doblin, who has a doctorate in public policy from Harvard, told Reuters.
The drug could help people with post-traumatic stress because it enabled them to let go of fear and emotionally work through an upsetting experience, he said.
``One of the main actions of MDMA is to help people deal with and integrate fear ... it reduces the fear response.''
An institutional review board at the Medical University of South Carolina, where the planned study would take place, must still approve the research before it can begin.
``Until such time that the board reviews and determines that the research meets ethical and legal standards, the protocol will not be tested'' on the campus, a university statement said. No decision was expected before January at the earliest.
In the proposed MAPS study, 12 patients would receive MDMA therapy in addition to psychotherapy. Eight patients would get a placebo and psychotherapy.
The patients in the MDMA group would receive the drug twice at sessions three to five weeks apart. Doblin said patients would be given the drug in a hospital and remain there overnight.
The study would only enroll patients who had not overcome their post-traumatic stress with previous psychotherapy and treatment with an antidepressant, he said.
Experts say as many as 8 percent of Americans experience post-traumatic stress disorder at some point in their lives.
Symptoms last longer than the depression or short-term stress that occurs after traumatic events. Patients can experience nightmares and flashbacks, feel emotionally numb or become irritable and easily startled.
The disorder can strike after military combat, rapes, domestic abuse or serious accidents. Some experts predict it will also affect many Americans trying to cope with the Sept. 11 attacks.
---------
WASHINGTON (Reuters) - A group that advocates the therapeutic use of psychedelic drugs said on Wednesday it had secured federal approval for the first study of Ecstasy, an amphetamine outlawed since 1985, as a treatment for post-traumatic stress disorder.
But the most likely site for such a study, the Medical University of South Carolina, said no decision had been made on whether to approve the research.
``FDA (news - web sites) officials ... informed me that the protocol was approved,'' said Rick Doblin, president and founder of the Multidisciplinary Association for Psychedelic Studies, in a statement.
The association, known by the acronym MAPS, has been trying for 16 years to win FDA permission to study Ecstasy as a psychotherapeutic agent. The organization hopes to develop Ecstasy into a prescription drug.
A spokeswoman for the Food and Drug Administration said she could not confirm or deny whether the agency had signed off on the trial, citing confidentiality rules.
Ecstasy, also known as MDMA, is an amphetamine that has both stimulant and hallucinogenic effects in humans. The drug is popular among adolescents and young adults who attend ``rave'' dance parties, clubs and rock concerts.
According to a Department of Justice (news - web sites) Web site (http://www.usdoj.gov/dea/concern/mdma/mdmaindex.htm), Ecstasy is not as widely available as some other drugs, but its use has increased significantly in the past decade.
The United States made Ecstasy illegal for medical or other uses in 1985.
Before that, many psychiatrists used MDMA in conjunction with psychotherapy, Doblin, who has a doctorate in public policy from Harvard, told Reuters.
The drug could help people with post-traumatic stress because it enabled them to let go of fear and emotionally work through an upsetting experience, he said.
``One of the main actions of MDMA is to help people deal with and integrate fear ... it reduces the fear response.''
An institutional review board at the Medical University of South Carolina, where the planned study would take place, must still approve the research before it can begin.
``Until such time that the board reviews and determines that the research meets ethical and legal standards, the protocol will not be tested'' on the campus, a university statement said. No decision was expected before January at the earliest.
In the proposed MAPS study, 12 patients would receive MDMA therapy in addition to psychotherapy. Eight patients would get a placebo and psychotherapy.
The patients in the MDMA group would receive the drug twice at sessions three to five weeks apart. Doblin said patients would be given the drug in a hospital and remain there overnight.
The study would only enroll patients who had not overcome their post-traumatic stress with previous psychotherapy and treatment with an antidepressant, he said.
Experts say as many as 8 percent of Americans experience post-traumatic stress disorder at some point in their lives.
Symptoms last longer than the depression or short-term stress that occurs after traumatic events. Patients can experience nightmares and flashbacks, feel emotionally numb or become irritable and easily startled.
The disorder can strike after military combat, rapes, domestic abuse or serious accidents. Some experts predict it will also affect many Americans trying to cope with the Sept. 11 attacks.
![[identity profile]](https://www.dreamwidth.org/img/silk/identity/openid.png){kind=small}
no subject
Date: 2001-11-08 06:32 am (UTC)good for them, i hope hope this works out,
even if it doesn't work out to be legal
and medically used, the permission of study
itself will open doors for other discriminated
against chemicals to be studied and researched...
i say this is a wonderful sign..
thanks for posting this!
no subject
Date: 2001-11-08 06:57 am (UTC)MAPS rocks sox. I've been on the MAPS list for about 3 years.