Regulators Approve Study of Ecstasy for Post-Traumatic Stress

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...

A political storm but one small step for man......

125mg sounds like an enormous amount for someone who may never have had the drug.
Of course it will be of purity we cannot even fathom.
Very good thing anyway; there is no doubt about MDMA's medical capabilities and if this can confirm it then we r one step there. If its proven to be medically valuable then it comes down to at least schedule 2.

It certainly hasn't worked for a certain person I know. It seems to have had a negative effect.
In a controlled environment tho, and maybe if they wise up and use responsible amounts.
Otherwise... I think I'll have to go get myself a job in a late night liquor store in South Carolina. Although I think I'd die if I took 125mg

Biscuit's point about MDMA being rescheduled is a big one. It was this scheduling to class 1 that stopped PTSD work with MDMA in the first place.
Class 1 = “No accepted medical use, and has potential for abuse”.
A bit hard to argue with the second bit, but a fight has always been fought on the other front. It’s been in the wind for some time that the DEA were coming round, Doblin being someone that has worked hard for the cause. The push from many areas of the medical community is considerable, as work done by Carlos Bouso from the University of Madrid has achieved significant success. Let’s hope it’s a matter of sooner rather than later that the IRB give it the tick, and also that Doblin gets the recognition he deserves.
There has been much said about the importance of 'correct' clinical setting with this therapy. Ann Shulgin and others state that ~120mg is initially given to the patient, followed by an optional supplement (usually 40mg) at the 1.5 hour point. It is explained that this does not increase the strength of the effect but will extend it an extra hour. Of course the patient is well prepared and guided through the experience.
These therapists often remark that in many cases, only one or two sessions are required to achieve breakthroughs, with PTSD sufferers often being particularly responsive.
The patient should also have had no prior experience with MDMA. As we all know those first times are usually like nothing following, so previous inexperience seems to greatly benefit MDMA supplemented therapy.
There are also many cases where E has had the reverse affect, by making worse an already existing or suppressed condition, but these are usually reported as recreational use related. For these reasons many PTSD therapists strongly oppose any recreational use of MDMA.
Still, this is great news. Eventual deregulation should mean possession will be a less severe offense than it is today. I wouldn’t be at all surprised though, if new legislation is introduced that continues to classify MDMA as a very naughty recreational drug, while still permitting doctors to have it as a powerful therapeutic aid. I wonder then would diagnosis of such conditions be expected to suddenly increase?
Perhaps it will be like the days of the early 60’s when anyone wishing to try LSD could do so legally in a clinical setting. Even Bert Newton had a go – and freaked out. Hardly a wonder, just imagine what an introspection exercise that would have been!

Personally i think its way too much. The positive effects of the experience are greatly determined by the "afterglow" effect i feel.
So a big dose which would be completely serotonin depleting isnt likely to have the nice after feel that perhaps a dose going about 2/3 of the way would.
Ann Shulgin is probably assuming the dose she would need
Maybe thats y it didnt work for your friend Entropope? as phase dancer said it seems to be only good for those who have not experienced it to a great degree; which does make sense.