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NEWS: US authorities reconsider ecstacy

off my pickle

Bluelighter
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Jun 23, 2003
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Crime victims sufferings from post-traumatic stress disorder are to be given MDMA (ecstacy) as part of a new study on the potential benefits of E.

the controversial new experiment hasjust been approved by Americas powerful FDA (Food and Drug Administration) after a 20 year period in which MDMA's illegality made it taboo for scientific research, despite its previous history as a wonder drug for psychotherapy.

the new study is vindication of sorts for the worlds foremost ecstacy expert Dr Alexander Shuglin, who complained bitterly about MDMA's research pariah status in his seminal pharmacology book TIHKAL (published in 1997).

"the fact remains that MDMA has proven extraordinarilly affective in many clinical applications and theraputic interventions," said Dr Shuglin.

here is a drug that has the unusual property of, more often than not, freeing a patient in therapy from the anxiety and lack of trust that often prevents the emotionally fragile person from expressing his feelings to another. And, has been attested to by many therapists and patients, MDMA allows a personal perspective, which is called insight with a minimum amount of fear and self-sensoring.All this without loss of self control or rationality.

tests on 20 crime victims are due to begin as early as january, subject to DEA licensing of the MDMA required for the experiment.

*taken from a sydney 3D world magazine*
 
It was actually announced some time in early 2002 that the DEA had agreed to start allowing trials of MDMA in PTSD therapy. In large, this was due to the extensive body of hard working academics involved with the then Lindesmith institute for Drug Policy Reform. Shulgin carried a lot of weight (power) in some ways, but obviously the DEA could not be seen to be beckoning to the call of a man known to have outsmarted them on previous occasions - and got away with it ;) A man also, who, in the eye of some, is largely considered responsible for the widespread illicit use of the drug.

But he is a good scientist with many astute colleagues to back up his suggestions. In regards to the approval, it's actually quite likely Shulgin played more of a back seat role in this push, as it's not so much a question of chemical properties (as opposed to pharmacological) but of clinical assessment, completely outside his area of expertise. His wife Ann is somewhat qualified in psychotherapy and has added her support to the push. Another most worthy of note is Rick Doblin from Maps. Some of these people have fought for the acceptance of MDMA in this field for longer than the the 17 years or so the drug has been banned.

Not wishing for a moment to shadow the deserved glory for Shulgin, but in all reality, this action by the DEA has only come from the pressure of many. If the DEA had their way (which they have till now) MDMA would be classified as having no medicinal value.8)

If it hadn't of been scheduled in 86 and then rescheduled in a year or so later,(Ricaurte again grrrrr....) MDMA may have changed the face of psychiatry over a decade ago, which effectively means we are possibly ten years behind in this field. It may well be the DEA has quite a bit to answer for :\
 
Ten years behind and getting a start is better than not getting a start at all. Hopefully this could be the beginning, leading to the use of MDMA for its medicinal value. Although I am sure it would still be abused and used by the wider community, it seems to carry many advantages that would be usueful to medicine.
 
I was a little out on my date. It was actually announced in 2001. There's seems to be nothing more recent on the site, and it doesn't address Psychadelic_Paisly's question. Anyway it may be of some value


FROM: Drug Policy Alliance (formally Lindesmith Institute)

FDA Approves Study of Ecstasy in Post Traumatic Stress Disorder
For Immediate Release: Wednesday, November 7, 2001. Contact: Tony Newman 510-208-7711 x 1383 or Shayna Samuels 212-547-6916


On Friday, November 2, the Food and Drug Administration approved the first clinical trial of Ecstasy (also known by its chemical name, MDMA) as a treatment for Post Traumatic Stress Disorder (PTSD). The study, to be conducted by Dr. Michael Mithoefer, is now awaiting approval from the research review board at The Medical University of South Carolina in Charleston.

This marks the first time the FDA has sanctioned a study exploring the potential of MDMA to treat a psychiatric disorder. Despite millions of illicit Ecstasy tablets consumed in this country, only three research groups have received permission to give MDMA to human subjects. "Despite the serious problems that can occur with uncontrolled use, there is good evidence that MDMA can be used safely in a controlled clinical setting," said Dr. Mithoefer. "The potential benefits from research that could lead to better treatment for patients suffering from chronic PTSD outweigh the minimal toxicity potential from therapeutic doses of MDMA."

The protocol outlines a double-blind placebo-controlled study, designed to investigate the safety and efficacy of two MDMA-assisted psychotherapy sessions conducted three to five weeks apart. Researchers will enroll twenty subjects who have PTSD as a result of crime victimization, including childhood sexual or physical abuse. The effects of 125 mg. of MDMA delivered within a controlled therapeutic setting to patients with chronic PTSD will be compared with placebo administered in otherwise identical sessions.

In the 1970s and 1980s, MDMA was used primarily by psychiatrists to help achieve breakthroughs in therapy. These same physicians sued the Drug Enforcement Administration when it filed motions in the Summer of 1984 to place the drug in the most restrictive category of controlled substances, Schedule I. Although the court proceedings resulted in a recommendation from the administrative law judge that the drug be placed in Schedule III, where clinical research could continue, the DEA opted to place MDMA in Schedule I, implying it had no medicinal value and a high potential for abuse. Since the Summer of 1985 when MDMA was placed in Schedule I, clinical research has been nearly impossible to perform while illicit use has gone largely unchecked. In the past five years, Ecstasy use has doubled among young people: eleven percent of American high school seniors and over thirteen percent of college students now report they have tried the drug.

"People are using Ecstasy in an unsafe manner and need to be educated about its risks," says Bellevue attending psychiatrist Dr. Julie Holland. "But being a popular illicit drug does not negate the potential medical benefits. There is strong anecdotal evidence that MDMA-assisted psychotherapy sessions, performed prior to the drug's scheduling, achieved real gains in patients with PTSD. MDMA provides an opportunity to process a trauma in a more comfortable atmosphere--similar to anesthesia which allows painful surgery to proceed."

Dr. Holland, Clinical Assistant Professor of Psychiatry at New York University School of Medicine, has compiled the opinions of twenty-two of the world's leading experts in the first comprehensive and authoritative book on MDMA. The Charleston protocol, and similar studies, are discussed in the newly released Ecstasy: The Complete Guide. A Comprehensive Look at the Risks and Benefits of MDMA, which details the history of MDMA-assisted psychotherapy, and explores the use of MDMA to treat psychiatric and medical conditions. This book also conducts a thorough review of the risks of Ecstasy use, and all current clinical MDMA research worldwide.

"MDMA is a unique compound with great potential for positive use. This is the most complete book about it, with much information to help people realize that potential as well as reduce any possible harm." --Andrew Weil, M.D.

Promotional copies are available from: Jody Winters, Publicist, Inner Traditions/Bear & Co. [email protected].
phone (505)982-3660
fax (505)989-8311
 
This also, but which doesn't look that good. Taken from here, dated 2nd Dec 2003


...The first FDA-approved study of the therapeutic use of MDMA in the 18 years since it was made illegal is also being held up by the Drug Enforcement Administration. Dr. Michael Mithoefer, the psychiatrist who would conduct the MDMA/PTSD study, has yet to receive his required Schedule I license since July 2002, when he first submitted his application. The Times article mentions that a study in Spain using MDMA to treat rape victims is underway, when in fact it has been prematurely shut down as a result of political pressure by the Madrid Anti-Drug Agency, aided in part by an anti-ecstasy climate created by Dr. George Ricaurte in his numerous recent talks in Spain, some at the invitation of the Spanish Anti-Drug Agency.....
 
EXCELLENT!
I am very pleased.
Now they'll just have to figure have to get past the "these feelings go back to my childhood days, this was when... errr... hang on... what was I talking about".
=D

But seriously.
It's good to see the "EVIL raver drug" going to some medicinal use (be it now or in the future).
Peace.
 
Killing_time said:
Now they'll just have to figure have to get past the "these feelings go back to my childhood days, this was when... errr... hang on... what was I talking about".

Hhahahahahaha so true.
 
a little OT:
I was thinking about the dosage levels they're going to be given the other day, which is about 120mg from memory.
Many said that this will be a very high dose for psychiatry as a +100mg MDMA pill is a VERY good one.
However, with the lack of stimuli around you, i think it would be a pretty good dose as MDMA is very setting orientated...

my 2c :)
 
I have read "Ecstacy: the complete guide" by Julie Holland, As mentioned in the drug policy alliance article posted by phase dancer.
Very informative & unbiased. Much of its focus is on the medical benefits as a possible treatment for not just PTSD but also Depression, Schizophrenia
it also helped me to understand a little more about the transformation & growth I have seen in myself since I became a very naughty pill popper.
If I ever end up in the "do you..." discussion with my mum, the first part of my answer will be to hand her this book.
a really good read, available on amazon.com for US $14 + $7 P&H. Royalties from the book go to clincal MDMA research.
More info relating to psychotherapeutic studies can be found at www.maps.org
 
Morphine..a drug of high abuse potential..but still allowed medically...why not mdma..trauma is real pain after all..whether mental or physical.
 
My car got broken in to once, do I qualify? jk


No disrespect to victims of serious crimes.
 
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