Bootlegger
Bluelighter
- Joined
- Dec 9, 2000
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Regulators Approve Study of Ecstasy for Post-Traumatic Stress
WASHINGTON (Reuters Health) Nov 07 - The federal government has given the go-ahead for an experiment involving the use of the club drug Ecstasy to treat post-traumatic stress disorder.
The study is being sponsored by a Florida group called the Multidisciplinary Association for Psychedelic Studies (MAPS). Rick Doblin, the group's director told Reuters Health that the research could begin at the Medical University of South Carolina in Charleston as early as February 2002.
Officials at the US Food and Drug Administration would not comment on the approval, though one official did confirm the accuracy of statements on the MAPS Web site claiming that authority had been granted.
Researchers propose to study the effects of Ecstasy, also known as MDMA, in patients with post-traumatic stress disorder due to violent crime. Twelve patients will be given two 125 mg doses of the drug about 4 weeks apart along with counseling sessions. A control group of 8 patients will receive a placebo along with their counseling.
Patients must have already tried traditional antidepressant medications with no response in order to qualify for the study.
Despite FDA's approval, the study cannot begin until investigators get clearance from both the university's research review board and from the Drug Enforcement Agency, which must grant licenses for any research using illegal drugs.
"Even if the FDA has approved the study, it does not give the researchers the authority to conduct the research," DEA spokesman Eric Williams said.
Ecstasy's spiking popularity among teens has alarmed health officials in recent years. The drug works to drastically elevate mood by releasing large amounts of the neurochemical serotonin in the brain. The drug, once used as an underground treatment for depression, was made illegal in 1985.
The experiment would not be the first to examine MDMA's use for post-traumatic stress. An ongoing trial in Spain is currently evaluating the drug in women who have experienced sexual assault.
Doblin said that drug enforcement authorities were likely to grant a license for the study since the substance will be carefully guarded and only administered in a hospital setting. But problems could arise when the research review council, called an institutional review board (IRB), evaluates the protocol in January. IRBs are skittish about controversial research, especially since the death of a patient in a clinical trial at Johns Hopkins University in Baltimore last June.
"We anticipate no problem with the DEA license. The IRB approval is another matter," Doblin said.
The Medical University of South Carolina issued a statement on Wednesday saying, "Until such time that the board determines that the research meets ethical and legal standards, the protocol will not be tested on the Medical University of South Carolina campus."
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And the Mission is the Mouse...
WASHINGTON (Reuters Health) Nov 07 - The federal government has given the go-ahead for an experiment involving the use of the club drug Ecstasy to treat post-traumatic stress disorder.
The study is being sponsored by a Florida group called the Multidisciplinary Association for Psychedelic Studies (MAPS). Rick Doblin, the group's director told Reuters Health that the research could begin at the Medical University of South Carolina in Charleston as early as February 2002.
Officials at the US Food and Drug Administration would not comment on the approval, though one official did confirm the accuracy of statements on the MAPS Web site claiming that authority had been granted.
Researchers propose to study the effects of Ecstasy, also known as MDMA, in patients with post-traumatic stress disorder due to violent crime. Twelve patients will be given two 125 mg doses of the drug about 4 weeks apart along with counseling sessions. A control group of 8 patients will receive a placebo along with their counseling.
Patients must have already tried traditional antidepressant medications with no response in order to qualify for the study.
Despite FDA's approval, the study cannot begin until investigators get clearance from both the university's research review board and from the Drug Enforcement Agency, which must grant licenses for any research using illegal drugs.
"Even if the FDA has approved the study, it does not give the researchers the authority to conduct the research," DEA spokesman Eric Williams said.
Ecstasy's spiking popularity among teens has alarmed health officials in recent years. The drug works to drastically elevate mood by releasing large amounts of the neurochemical serotonin in the brain. The drug, once used as an underground treatment for depression, was made illegal in 1985.
The experiment would not be the first to examine MDMA's use for post-traumatic stress. An ongoing trial in Spain is currently evaluating the drug in women who have experienced sexual assault.
Doblin said that drug enforcement authorities were likely to grant a license for the study since the substance will be carefully guarded and only administered in a hospital setting. But problems could arise when the research review council, called an institutional review board (IRB), evaluates the protocol in January. IRBs are skittish about controversial research, especially since the death of a patient in a clinical trial at Johns Hopkins University in Baltimore last June.
"We anticipate no problem with the DEA license. The IRB approval is another matter," Doblin said.
The Medical University of South Carolina issued a statement on Wednesday saying, "Until such time that the board determines that the research meets ethical and legal standards, the protocol will not be tested on the Medical University of South Carolina campus."
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And the Mission is the Mouse...