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Ecstacy Approved for Human Trials by FDA
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| Swamper |
http://www.wired.com/news/print/0,1294,48547,00.html
Getting the FDA Hooked on Ecstasy
By Kristen Philipkoski
2:00 a.m. Dec. 10, 2001 PST
An advocate of psychedelic drugs is doing something that Ken Kesey and Timothy Leary thought unthinkable: cooperating with government bureaucrats.
Rick Doblin and his colleagues at the Multidisciplinary Association for Psychedelic Studies (MAPS) have put together the first FDA-approved human study in 16 years using Ecstasy (MDMA) as a therapy aide.
It's the first step on a path that Doblin hopes will lead to making certain hallucinogens legal for the treatment of psychological disorders.
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Doblin has become the ultimate insider-outsider. Working from within the system, he has already won the battle to get Ecstasy into a clinical trial.
"Being seen as counter-culture defines you as being on the outside," Doblin said. "Going through the Kennedy School was an identity shift -- not that I'll ever really be welcome on the inside."
With a PhD in public policy from Harvard's John F. Kennedy School of Government, he has managed to remain friends with the trippers while working within the extremely rigid public policies of the FDA. He's the only person who could get the FDA to approve a Schedule 1 drug for human trials, many say.
"He's a deeply honest and principled dude," said John Heilemann, author of Pride Before the Fall and a special correspondent for Wired magazine.
Heilemann said he teases Doblin about being a hippie, but he doesn't lump him with other tie-dyed, manifesto-wielding psychedelic advocates.
"People who are all hippie-dippy, I don't have much time for. But his (hippie-dippiness) is married to a pragmatic sensibility," he said.
It's a balancing act that Doblin believes is key to changing a deeply bureaucratic system.
The clinical trial will test whether Ecstasy, used simultaneously with psychotherapy, can help people with post-traumatic stress disorder (PTSD). Many of the patients will be victims of sexual assault or abuse.
"It's been key that we very much worked within the system and approached it from a scientific point of view," said Dr. Michael Mithoefer, a psychiatrist with a private practice in Charleston, South Carolina, who will run the trials. Many of Mithoefer's patients suffer from PTSD.
Twenty patients diagnosed with PTSD will be recruited for the study by early next year. Twelve will receive 125 milligrams of MDMA on two occasions, and eight will get a placebo. Neither the patients nor Dr. Mithoefer will know who got what.
While the patients are under the influence of either the drug or the placebo, they will participate in therapy sessions between six and eight hours long. Each patient will undergo an additional 11 therapy sessions between 60- and 90-minutes long to prepare the subjects.
The nod from the FDA is the first milestone in Doblin's grand plan to take perception of MDMA "out of the frame of kids dancing all night and into the realm of helping people who are depressed," he said.
Approaching the government on its own terms could result in any of three scenarios, said John Gilmore, a founder of the Electronic Frontier Foundation, fifth employee of Sun Microsystems and newly appointed board member of MAPS.
Researchers may learn that the substance doesn't have therapeutic use, but the research will no longer be banned. Or, they'll learn that it does have therapeutic use, but the government will not follow its own rules -- to approve drugs that are safe and have therapeutic value -- which Gilmore said would be key knowledge, as it would instigate reform. Or, they'll learn that the drugs do have therapeutic use, and people will use them.
"It serves an important function either way," Gilmore said.
Looking at psychedelic drugs as a tool to help people function better in mainstream culture is dramatically contrary to the revolutionary bent of Kesey and Leary.
Presidents Lyndon Johnson and Richard Nixon were the leaders of their time, and people didn't feel in control of their country, Gilmore said. Rather, they felt controlled by it, so Kesey and Leary's approach made sense at the time.
"Were it not for Timothy Leary and Ken Kesey, Rick Doblin probably wouldn't have started this work," Gilmore said.
While Doblin said they've inspired him, he also said he isn't emulating their techniques.
"A more effective approach is to go beyond the conflict and into the integration," Doblin said. Many drugs, not just psychedelics, integrate well with mainstream culture, he said.
"I've recently realized how great marijuana goes with reading Harry Potter bedtime stories," said Doblin, who has three children, ages 6, 5 and 3.
One of Doblin's greatest pleasures since the news of the FDA trial approval came out, he said, was seeing it announced in a Food and Drug Law Institute newsletter, which goes to clinical psychologists.
An interview request from the American Association of Retired Persons (AARP), which will run a piece on the Ecstasy trials this spring, made him equally giddy.
"If I can get the AARP behind psychedelic medicine, we're in luck," he said.
The National Institute of Drug Abuse paints a dismal picture of psychedelics. NIDA's website says the drugs result in neurotoxicity, violence and crime.
Ecstasy is methyldioxymethamphetamine, or MDMA, and was deemed a Schedule 1 drug by the Drug Enforcement Administration about 15 years ago.
Some researchers, such as George Ricaurte, believe MDMA is too dangerous to give to humans under any circumstances.
Ricaurte, who works in the department of neurobiology at Johns Hopkins University School of Medicine, has published research showing that monkeys still showed damaged serotonin axons seven years after they were given MDMA.
When MDMA was deemed illegal, many therapists were already using the drug as a therapy tool.
Today, underground psychotherapists risk their livelihood to treat people with Ecstasy and other psychedelics such as lysergic acid diethylamide (LSD), gamma hydroxybutyrate (GHB) and ketamine (also called Special K).
Doblin modeled the MDMA trial after the trials that got the anxiety drug Zoloft approved. Members of MAPS have spent the past two years getting advice from Pfizer researchers who worked on the Zoloft trials.
He didn't always play by the rules, however.
He avoided registering for the draft, when he turned 18 in 1971, and expected to be caught and sent to prison. As it turned out, he was never caught and he was never drafted because he wasn't in the system.
But convinced he would soon be a convict, he worried he'd never have an upstanding professional career. He enrolled at New College in Sarasota, Florida, with hopes of becoming an "LSD therapist."
He lasted there about three months, distracted by LSD, all-night parties and skinny-dipping in coed pools.
"I took too much (LSD) and dropped out for 10 years knowing I would go back," Doblin said. "In the meantime, I tried to build things. I built a house when I was 21 that's sort of a house to trip in."
The house is now the MAPS headquarters in Sarasota, Florida.
Finally in 1982, he became a college freshman at age 28. After completing his undergraduate studies, he went directly to the Kennedy School.
His commitment to legalizing Ecstasy and being 10 years older than his classmates made him an unusual student -- a fact that was not missed by Heilemann.
The Kennedy School had a "face book" that Heilemann compared to a summer camp meet book. It included photographs and resume details of each new student.
He remembers flipping through it and trying to find interesting people.
"There were a lot of really boring people with very conventional backgrounds," he said.
But Doblin's bio jumped out, talking about his involvement in drug research, particularly with MDMA.
"I was very interested in psychedelics, having taken a lot of them in college," Heilemann said.
When Heilemann was introduced to Doblin at a picnic he blurted: "You're the Ecstasy guy!" They were fast friends.
The drug is still a mystery to many, but Doblin hopes the clinical trials will make it the new "Prozac-plus." It's potentially a better option than drugs such as Prozac or Zoloft, Doblin said, because the symptoms of post-traumatic stress often return when patients stop those medications.
With MDMA therapy, patients would take it just once or a few times in conjunction with psychotherapy, then integrate the experience in future psychotherapy sessions without the drug.
"Instead of making pharmaceuticals wealthy and making people dependent on a drug," Doblin said, "this is the anti-drug drug."
Copyright © 1994-2001 Wired Digital Inc. All rights reserved. |
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| SYNthSRI |
wasn't MDMA used as medication for depresants long time ago and was banned due to it's hallucinogen properties?
not sure...but overall, imho, think this is a step in the right direction. |
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| Juricimo |
some time ago i read that MDMA in pure form was not very harmful if at all....but i'm still not up to trying the Mitsubishis or any others...i've read those are mixed in with all sorts of other that scares me a bit.....maybe i'm just a wuss:D
>JM< |
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| biznology |
well however this turns out, we can at least begin to know some of the long term effects of the drug, which hasnt really been studied in humans. it was and interesting article and i think Doblin is going about this thing the right way. it will also make it a regulated substance if it passes, taking alot of the 'guesswork' out of what you are taking...
from what i know about MDMA, it was first produced by Merck chemicals in the early 20th century. it was used off and on as a psychotherapy drug, but usually avoided because of how easily patients built up a resistance to it (making the 2 doses for the trials ideal). it was also used as riot contol in South Africa for a period. ecstasy was largely overlooked in the drug scene until about the 1980s, when by virtue of it being a methamphetamine, it was labeled schedule one, along with many other drugs in Nancy Reagans 'War on Drugs'.
^^ this may be in some ways true, but this is what i know about it so far...if anyone else can add/correct that would be cool.
late/ |
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| twilochik |
| MDMA was used alot for counseling the depressed...it was also used for marriage counseling. But if you compare the way MDMA works with current anti depressants it is not as effective. MDMA causes a surge in Seratonin in the brain. Which is great...at first...but it everntually causes worse depression bc your body cannt keep producing such large amounts of Seratonin...hence kids getting depressed or burned out after repeated use of ecstasy. Current anti drepressants work to keep a stable level of seratonin in the brain at all times. It regulates the output of seratonin and regulates the brains intake of it as well. It creates an equilibrium in the brain...MDMA does not have those features and I think that is why MDMA was eventually stopped being used. Just my thoughts on it all. I took intro to Psych this semester and we learned exactly how the anti depressants work. Rather interesting. But ecstasy is not just MDMA. Ecstasy the designer drug is often paked with chemicals other then just MDMA. I think this study is far more geared towards the effects of "ecstasy" rather then just MDMA...since they already know the effect of the chemical MDMA on its own. |
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| SYNthSRI |
| quote: | Originally posted by Juricimo
some time ago i read that MDMA in pure form was not very harmful if at all....but i'm still not up to trying the Mitsubishis or any others...i've read those are mixed in with all sorts of other that scares me a bit.....maybe i'm just a wuss:D
>JM< |
heh, yea I believe on avg, there's like 30% mdma in tabs like bmw and bit more in tabs like white dove
"friend" of mine has tried "pure" mdma, he peaked for longer and the effects were "stronger" according to the "friend".
My knowledge of the history with MDMA is vague, but as someone pointed out, it WAS used at certain marriage counseling places. If what is being "tested" is ECSTASY, and not MDMA, even better! This will be interesting, to see what type of effects it has on a human body. |
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| torontotrance |
| Imo they find out ecstacy has serious health implications, they will find out more than before. I say ban it, i'm sick of the drug period. You want to do drugs legally, go to denmark, all drugs are LEGAL there. Maybe if we knew more about E, we could stop the needless deaths of ppl. I'm all for getting as much information as we can on things and allowing ppl to make informed decisions. But i think BOTH sides should be presented to ppl before making a decision like taking E, the pros and cons and the legal view of it. |
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| TranceXtasy |
Just to clarify some matters here. Firstly, MDMA is not to be used as an anti-depressant in the traditional sense such as the prevelant SSRIs are. Its theraputic value will be extracted in the context of a psychotherapy session in the treatment of PTSD. Ongoing studies in Spain, Israel, and Switzerland point to the effectivness of using MDMA as a checmical aid in the treatment of this psychological disorder. MDMA has the wonderful ability of temporarily breaking down our "ego defences", hence, providing us with the ability to tackle deep seated issues which normaly cause too great of a turmoil to be accessed, and disscussed about in a rational manner. I know that through the use of MDMA, I personally have been able to become more insightful in introspective sessions, and intertwine these new found revelations with stringent cognitive rationale.
Secondly, ecstasy is just a street term for(methylenedioxy-n-methylamphetamine). In an ideal world ecstasy would be pure MDMA, unfortuantely, unscrupulous manufacturers adulterate MDMA with other substance of lesser value. Consequently, many people have gathered the notion that ecstasy and MDMA are two different substances. In essence they could be, but ultimately they should be one of the same. Findings from DEA, and FBI point to the average ecstasy tablet as containing between 80 and 110 mg of MDMA with the range being 0-160mg. The purity has also been show to improve since early and mid 90s. I have been lucky so far to get pure MDMA every time(at least to the best of my knowledge). It is really essential to know the source. The one advantage of MDMA being in a pill form, is that its quality will not be degraded as it slowly trickles down the chain of dealers. |
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| biznology |
| quote: | Originally posted by torontotrance
Imo they find out ecstacy has serious health implications, they will find out more than before. I say ban it, i'm sick of the drug period. You want to do drugs legally, go to denmark, all drugs are LEGAL there. Maybe if we knew more about E, we could stop the needless deaths of ppl. I'm all for getting as much information as we can on things and allowing ppl to make informed decisions. But i think BOTH sides should be presented to ppl before making a decision like taking E, the pros and cons and the legal view of it. |
it is banned right now...and why would they ban it even if it helped people? i DO think people should be informed tho, and tho you may find it to be PRO drug use, most of what floats around right now, especially about E is propaganda. sure SOME x deaths are from PMA or whatever, but most are from dehydration and heat exhaustion, which ARENT drugs the last time i checked. banning it wont get it out of the media, culture or coroners reports im afraid, it can really only make things worse. late/ |
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| TranceXtasy |
Besides the deaths attributed to PMA, a lot of cases especially in the U.S, that been attributed to ecstasy (MDMA), have actually been caused by (2,5-dimethoxy-4-(n)-propylthiophenethylamine, AKA substance 2C-T-7. Of course, jumping on the Ecstasy propaganda bandwagon, the media did not put forth the effort to bring us the truth, but rather further bastardized MDMA!
:mad: :whip: :mad: |
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