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  1. chillinwill
    Pilot studies demonstrate effectiveness of MDMA for post-traumatic stress disorder

    Ecstasy, a drug that is illegal in most countries, is showing increasing potential as a treatment for post-traumatic stress disorder (PTSD), according to clinical-trial results presented at a conference in San Jose, California, today. The effect seems to continue for years after the initial treatment.

    People can develop PTSD after traumatic experiences such as sexual abuse, or witnessing extreme acts of violence. Patients are plagued by flashbacks and nightmares, and often become emotionally numb and easily frightened. Treatment includes cognitive behavioural therapy and selective serotonin reuptake inhibitors (SSRIs) such as paroxetine (Paxil) and sertraline (Zoloft), but many people with PTSD do not respond to these treatments.

    Ecstasy, otherwise known as MDMA (3,4-Methylenedioxymethamphetamine), causes the release of neurotransmitters such as serotonin in the brain, and so could help to decrease the patient's fear and defensiveness during treatment The drug was used during therapy in the 1970s but with the rise of rave culture in the 1980s, the US Drug Enforcement Agency and the World Health Organization listed MDMA as a Schedule I drug — a classification reserved for drugs with no medical use and high potential for abuse — making it nearly impossible to use in clinical trials.

    Since 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit research group based in Santa Cruz, California, has struggled to obtain permission to study the therapeutic potential of MDMA, other psychedelic drugs and marijuana, but now the group's efforts are beginning to bear fruit. The first two preliminary human trials, in the United States and in Switzerland, have had encouraging results, with most of the people with PTSD who were tested showing lasting improvements.

    "The results were very promising, and there were no safety problems or serious adverse events, but we need to replicate this," says Michael Mithoefer, a psychiatrist based in Mount Pleasant, South Carolina, who led the US study.

    The results were presented on Friday at the Psychedelic Science in the 21st Century conference, hosted by MAPS, which funded both pilot studies.

    Promising pilot

    The US study was the first in the United States to look at the therapeutic effects of MDMA on PTSD, and was completed in late 2008. The 20 patients, mostly women, had been resistant to psychotherapy and standard PTSD drugs. Therapists administered MDMA to the patients during two or three 8-hour "experimental sessions", spread amongst a series of 20 to 30 psychotherapy sessions.

    Two months after the last session ended, only 15% of the patients who received MDMA still met the criteria for PTSD, whereas 85% of the placebo group did.

    In long-term follow-up, averaging 3.5 years after the initial treatment, most of the people remained free of PTSD — of the 16 patients who participated in the follow-up study, 13 still did not meet the criteria for PTSD. Mithoefer notes, however, that the people who have not yet elected to participate in the long term follow-up may have done so because they had not fared well.

    "It's interesting, and sounds promising," says Kathleen Brady, a psychiatrist at the Medical University of South Carolina. But she notes that it's difficult to interpret the findings because the therapists were able to work out which patients received MDMA and which received placebo. "They could have been biased and treated the patients differently. That's definitely a concern."

    In the second study, Peter Oehen, a psychiatrist in Biberest, Switzerland, followed the same protocol with 12 people with treatment-resistant PTSD. Although some people treated with MDMA showed an improvement in their symptoms, the results from this trial were not statistically significant.

    "In a way the results were good enough to get approved as prescription medicine," says Rick Doblin, MAPS founder, pointing out that the SSRIs Zoloft and Paxil, which have FDA approval for treatment of PTSD have even more modest benefits for patients. "But it's true they were not as good as the US study. We're trying to understand why. It could very well be cultural variables, or therapist variables. We know it's not just the drug that does the work."

    The difficulty with replicating the success of the US trial is not very surprising, says Murray Stein, a psychiatrist at the University of California, San Diego, who is director of a 10-site clinical consortium devoted to researching PTSD and traumatic brain injury.

    "PTSD, and all of mental health research, is full of small, well-done studies that never get replicated," he says. "I'd love to see a bigger, well-powered study done. But until then, it's just kind of neat, but something I've seen 20 times before, something that often doesn't pan out."

    Cross cultural?

    MAPS has initiated a pilot study with US veterans and wants to run experiments in other countries, both to make sure the drug works in different cultural contexts, and to make the approval as a prescription medicine more likely. The group is now working to get approval for studies of MDMA for PTSD in four other countries: Canada, Israel, Jordan and Spain. But with these different governments and cultures come new hurdles.

    "Things are much slower than we expected in Canada, where we'd be the first psychedelic research in 40 years," says Doblin. "And the biggest stretch is going to be in Jordan. That's a culture where the psychedelic experience of the 1960s didn't happen, so there's no reservoir of therapists and psychiatrists that know about these things from when they were younger."

    That historical difference makes the Jordan study particularly important, says Doblin. "We want to show that these drugs can be mainstream," he says. "It's not just for people who have done drugs before. It's for normal people, for anyone."

    Lizzie Buchen
    April 16, 2010
    Nature News
    http://www.nature.com/news/2010/100416/full/news.2010.188.html

Comments

  1. Terrapinzflyer
    why oh why must they call it "ecstasy" ?!

    I was at the conference and heard the reports. And yes- the results were nothing short of amazing.

    There was a wonderful ancedotal report from Julie Holland MD, long time on the psychiatric ward of Bellevue of an individual who was a frequent patient at Bellvue, a "thug", always out of control on pcp who one day came in after ingesting mdma- she realized what was going on and the short window she had to work with- got to the root cause- childhood abuse, and changed his life- he finally left the city and went to be with his "wife" and child across country. The potential of these substances is nothing short of amazing.
  2. Rainbowzz
    My friend swim wanted me to type out the following for her, as it is her personal experience with this very subject.

    "I can verify from personal experience, that this drug DOES in fact, seem to be an EXCELLENT catalyst for healing, doing therapy, and several mental health issues related to abuse and trauma.

    As someone who suffers from such things as Borderline Personality Disorder, PTSD, Panic Disorder, and Dissociative Disorder(rather not say which DD), I have both informally and formally taken this drug with regard to making progress with my trauma.

    It actually started out very innocently. I had been doing the drug for a few months when I began noticing that often, when it was just me and a good few friends, or just me and one friend, the conversation would seem to naturally turn to that point of my life, and it was EASY to talk about, WITHOUT getting caught up and re-traumatizing myself. I found that I could even discuss memories, and even the exact situation causing trouble, and I did not dissociate, or have flashbacks, or even have an anxiety attack.

    I did have a few sessions with a friend who was also a psychonaught and psychologist. These were also somewhat informal and definetly not prescribed in any way - I just wanted to see where we could get.

    I, today, feel that a good majority of my progress through these disorders has been directly because of the fact that I spent a few years of my life involved with this drug. Though I RARELY do it now, there are without a doubt long term benefits to this as a medication."
  3. chillinwill
    Could ecstasy ease PTSD symptoms?

    Adding MDMA - otherwise known as the party drug ecstasy - to talk therapy may help patients cope with symptoms of post-traumatic stress disorder (PTSD), according to a preliminary study presented Friday at the Psychedelic Science in the 21st Century meeting.

    [IMGR="black"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=14270&stc=1&d=1271775946[/IMGR]
    The improvements endured long-term for most patients, said lead investigator Dr. Michael Mithoefer, a psychiatrist in private practice in Charleston, South Carolina.

    MDMA gained notoriety in the 1980s as a recreational drug, and the Drug Enforcement Agency outlawed it in 1985. Before then, a small network of therapists had experimented with the drug as an adjunct to traditional talk therapy.

    The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) launched Mithoefer's study in 2004 as the first step toward developing MDMA as a prescription medicine for use in therapists' offices.

    There were 20 patients in the study, all with moderate to severe PTSD that had not improved with standard treatments. The researchers found that patients taking MDMA had lower scores on standard PTSD symptom tests two months after the study, and also after more than three years.

    More than half of the patients - 13 - no longer met criteria for PTSD. However, two patients "clearly relapsed," Mithoefer told Reuters Health, and it's unknown what happened to four of the patients.

    Many of the patients also resumed taking antidepressants and anti-anxiety drugs after the study, but "they were on many fewer medications than when they started" the trial, Mithoefer said.

    "We think MDMA gives people four to six hours...where they can process their trauma," said Mithoefer. The drug appears to reduce the fear of engaging with painful memories, he added, as all patients receiving MDMA voluntary recounted their trauma while under its influence.

    The 2-3 day long MDMA sessions were sandwiched between 10 to 15 sessions of traditional psychotherapy. Mithoefer reported no significant side effects after a total of 51 MDMA sessions.

    Although the study was "blinded," meaning that patients did not know whether they were receiving MDMA, Mithoefer acknowledged that the drug often evokes powerful emotions, which may have tipped off patients and their therapists. Studies now getting underway will hopefully address this limitation, he said.

    A psychiatrist not involved in the study, Dr. Ben Sessa of the Somerset National Health Service Trust in the United Kingdom, said MDMA-assisted psychotherapy "is in a very experimental phase," and that it "obviously requires a lot of time, effort, and skill on the part of the therapist." Still, he called the findings "hugely significant."

    Brian Vastag
    April 19, 2010
    National Post
    http://www.nationalpost.com/life/health/story.html?id=6c2cdc9c-2654-4061-8b4f-aede99ad4534
  4. godztear
    MDMA is a pretty powerful drug. SWIM believes it actually IS the drug that does the work, otherwise the numbers wouldn't be so great for improvement in the disorder of those taking MDMA vs placebo. SWIM thinks they just threw that one liner in there to try and talk MDMA down and not glorify it too much.
  5. Terrapinzflyer
    ^^ actually- it may be related to a quote from one of the test subjects- (related by the researchers at the MAPS conference)

    "this is me, the medicine helps, but this is me"

    Essentially saying the drugs are not physiologically fixing something- but allow one, often for the first time in their life, to actually confront and deal with the deep rooted problems that cause so much trouble.
  6. chillinwill
    Can the Peace Drug Help Clean Up the War Mess?

    At a conference last weekend, researchers reported positive results on the effectiveness of MDMA in relieving PTSD and talked about psilocybin in reducing stress in late-stage cancer patients


    Michael Bledsoe's story begins like that of many other Iraqi war veterans. In 2007, he was chasing insurgents through Anbar province when a roadside bomb exploded, breaking Bledsoe's back and both his feet. A former Army Ranger working as a security contractor, Bledsoe soon knew his high-paying military career was over.

    Back home, Bledsoe (not his real name) felt angry almost constantly. Nightmares haunted him. He withdrew and became isolated. "It was a serious sense of loss," he says. His psychiatrist quickly diagnosed post-traumatic stress disorder (PTSD).

    Despite months of talk therapy, the nightmares continued, and Bledsoe grew desperate. Then "something almost miraculous" happened, he says. An online search brought him to a unique study of the banned drug MDMA (3,4-methylenedioxymethamphetamine), well known as the street drug ecstasy. The 21-patient study, sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), launched in 2004 as the first U.S. clinical trial of a psychedelic drug in 35 years.

    After several bond-building sessions with psychiatrist and study leader Michael Mithoefer and a co-therapist, Bledsoe swallowed a white tablet, donned eyeshades and reclined in Mithoefer's comfortable Charleston, S.C., office. Over the next eight hours, Bledsoe revisited the explosion and recounted the trauma to Mithoefer. After two more MDMA-assisted psychotherapy sessions, Bledsoe says his PTSD symptoms were "completely eliminated."

    This weekend at a MAPS-sponsored meeting here, Mithoefer reported similar results for nearly all of the trial's participants. After two or three MDMA sessions, patients who received MDMA experienced huge drops in symptoms as measured by a standard PTSD scale. At baseline, study patients had an average Clinician-Administered PTSD Scale (CAPS) score of 79, but after MDMA-assisted therapy, CAPS scores dropped to 23.4 in the 13-person MDMA group, whereas an eight-person placebo group averaged a score of 60. (Later, seven of eight placebo patients chose to receive MDMA as well.)

    The improvements appeared to endure, Mithoefer reported. After an average of 3.5 years, 13 of 16 patients remaining in contact with the researchers no longer met the criteria for PTSD. However, two of the patients "clearly relapsed," Mithoefer says. In addition, many of the patients returned to using antidepressants and other psychoactive medications, though the total number of prescriptions in the group was much lower than before.

    Julie Holland, a psychiatrist in New York City who used to work at the James J. Peters VA Medical Center in the Bronx, says the data "look really great. It's amazing that when patients are done with therapy, they don't meet criteria for PTSD. I've never even seen that. It's a very big deal." If MDMA were legal, Holland added, she would "absolutely" use it in her practice.

    Brain-imaging studies in healthy volunteers show that MDMA quiets the amygdala, an almond-shaped structure deep in the brain that some researchers call a “fear center” due to its central role in triggering strong negative emotions. MDMA also releases a flood of the brain messengers serotonin and dopamine while increasing blood levels of the hormones oxytocin and prolactin, which promote social bonding. This potent mix diminishes fear and defensiveness and boosts empathy and the desire to connect with others, says Holland, so “the therapy work goes faster and deeper.”

    Veterans suffer very high rates of PTSD, according to surveys. One 2004 study in The New England Journal of Medicine estimated that up to 18 percent of Iraqi and Afghanistan combat veterans experience the disorder. "This is our way of trying to contribute to our moral obligations to our veterans," says MAPS founder and executive director Rick Doblin. He added that the U.S. Department of Veterans Affairs has rejected overtures from MAPS to work together on five separate occasions.

    The U.S. Food and Drug Administration (FDA) has been friendlier to the group. This month, the agency granted MAPS permission to continue testing MDMA in 16 additional veterans with PTSD. But the road to full FDA approval is long and expensive, and Doblin anticipates five to 10 years of additional trials. He envisions eventually building a network of psychedelic therapy centers.

    A dedicated network of therapists experimented with MDMA-assisted psychotherapy in the 1970s and 1980s before the U.S. Drug Enforcement Administration banned the drug in 1985. The next year, Doblin launched MAPS to revive psychedelic research, a movement that's now gaining steam. A dozen human studies of MDMA, LSD, a powerful African drug called ibogaine and psilocybin, from so-called "magic mushrooms," are now under way, testing the once-stigmatized drugs as treatments for not only PTSD, but also cluster headaches and addiction, as well as anxiety and depression in cancer patients.

    Charles Grob, a psychiatrist at Harbor-UCLA Medical Center, dosed 12 end-stage cancer patients with psilocybin to test whether the experience could ease anxiety and help the patients cope with their diagnosis. Grob did not present his data, which are under review for publication, at the San Jose meeting, but the buzz on the results is positive. Grob and his co-investigators did offer snippets of letters and reactions from study patients. One said, “It feels like healing.” Similar studies of psilocybin in the terminally ill are now launching at New York University in New York City and Johns Hopkins University in Baltimore.

    However, the going has been slow, with Doblin carefully dotting every regulatory "i" to prevent a second backlash against psychedelics. "This isn't the '60s," he says. "We've learned the lessons of that era, and now we're trying to integrate ourselves into science, into medicine, into society."

    At the San Jose meeting, dubbed "Psychedelic Science in the 21st Century," that integration was in full swing. Eleven hundred therapists, physicians, basic researchers and psychedelics enthusiasts gathered for three days of scientific and cultural talks, visionary art shows and late-night celebrations. The unlikely mix found conservatively dressed researchers from prestigious universities mingling with the heavily tattooed and the green haired.

    As for Bledsoe, he's now a true believer. His MDMA sessions were "an almost sacred experience, a very special and uplifting experience," he says. After the therapy, he vacationed in Jamaica, began dating a local woman and bought a house on the island. "I'm happy and well adjusted now," he says. "It's a good fairy-tale ending. As soon as we get some little Bob Marley kids it'll be even better."

    By Brian Vastag
    April 20, 2010
    Scientific American
    http://www.scientificamerican.com/article.cfm?id=mdma-drug-ptsd-trauma-psychedelic
  7. Terrapinzflyer
    ok- first off - disclaimer: in this context, as news, I believe price discussion to be fair game- but please do not contine this discussion into the real of "street" mdma/ecstasy...

    At the MAPS conference, David E Nichols, who made the MDMA for all the US (and I believe it is to be used in the upcoming Canadian study) stated that 2 kilos were produced, at a rough cost of $1500 per kilo. While I did the math in my head at the time I believe this works out to somewhere around $0.90-$1.40 per dose (assuming 100-150mg dose). As the patent on MDMA is long since expired, this will be one amazingly inexpensive generic drug if it once again becomes legal for therapeutic use.
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