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Ecstasy Helps Treat PTSD Patients, Trial Finds

By Tamis, Jul 19, 2010 | Updated: Jul 19, 2010 | | |
  1. Tamis
    People suffering from the agony of post-traumatic stress disorder (PTSD) may one day find relief with Ecstasy.

    A small clinical trial found that 80 percent of participants treated with a combination of methylenedioxymethamphetamine (MDMA) and psychotherapy no longer showed signs of PTSD, with no serious side effects.

    Three people who also said the disorder prevented them from going to work were able to return to their jobs after the treatment.

    The study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct since it was criminalized in 1985 owing to recreational use of the drug, known by its street name Ecstasy.

    Twenty patients who had suffered with chronic PTSD for an average of more than 19 years and who had not obtained relief from both psychotherapy and psychopharmacology were randomly assigned to two eight-hour psychotherapy sessions, with 12 subjects receiving the drug and eight receiving a placebo.

    Both groups also received psychotherapy before and after the drugs were administered. Follow-ups were conducted four days and two months after each day-long session.

    At all recorded times after baseline, a decrease in Clinician-Administered PTSD Scale scores was significantly greater for the group that received MDMA than for the placebo group.

    The rate of clinical response, according to diagnostic criteria for PTSD as stipulated in the DSM-IV-TR, was 83 percent in the active treatment group, versus 25 percent in the placebo group.

    Investigators did detect raised blood pressure and other symptoms in the MDMA group. But there were no drug-related serious adverse events, adverse neurocognitive effects, or clinically significant blood pressure or temperature increases.

    A long-term follow-up evaluating the same subjects is underway.

    The authors did state that most participants accurately guessed whether they were receiving MDMA or the placebo, which has no psychoactive effect. The trials also did not look at gender or ethnic factors in their sample selection.

    The study's authors also admit that the two all-day therapy sessions and overnight stays at the clinic are not usual features of outpatient psychotherapy. But they believe that MDMA-assisted psychotherapy can be administered to PTSD patients without evidence of harm, who have been resistant to other treatments.

    The study, published today in the Journal of Psychopharmacology, was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) which, through its MDMA Psychotherapy Research Fund, hopes to develop MDMA into an FDA-approved prescription medication for therapeutic use in conjunction with PTSD.

    The trials were led by MAPS' President Rick Doblin, Ph.D., South Carolina-based psychiatrist Dr. Michael Mithoefer, and colleagues with the Medical University of South Carolina in Charleston.



  1. RaverHippie
    Ecstasy May Ease PTSD Symptoms

    Designer Drug Ecstasy Combined With Therapy Successfully Treats Posttraumatic Stress Disorder, Study Says

    The street drug known as ecstasy may play a role in treating severe posttraumatic stress disorder (PTSD) when used in conjunction with intensive therapy in a very controlled setting, according to preliminary new research in the Journal of Psychopharmacology.

    When used in this manner, MDMA, also known as ecstasy, was so effective that 80% of participants had resolution of their PTSD symptoms after the end of the trial. And some participants who had been unable to work because of their symptoms were able to rejoin the workforce. The new work was funded by the Multidisciplinary Association for Psychedelic Studies, a nonprofit group based in Santa Cruz, Calif., that studies the use of psychedelic drugs and marijuana in difficult-to-treat conditions.

    PTSD is an anxiety disorder that occurs after a traumatic event. It is marked by persistent thoughts and fears of the event, flashbacks, and sleeplessness. Some people with PTSD withdraw from society as a result of these debilitating symptoms.

    31 Hours of Therapy in 2 Months

    The new study included 20 people with chronic PTSD lasting an average of more than 19 years. They took part in two, all-day therapy sessions spaced about three to five weeks apart. Twelve participants received MDMA, while eight received a placebo pill during these sessions. They also had a prep session before therapy, a debriefing session afterward, and spent the night in the clinic on treatment days. In addition, participants were in phone contact with their therapist for the week after therapy. All in all, they spent about 31 hours in therapy during the two-month study.

    Eighty percent of participants who took MDMA were no longer classified as having PTSD after two months. After two months, participants in the placebo group were offered the study drug. Seven of eight opted to add the MDMA, and did equally as well as their counterparts who took the medication initially.

    “We don't yet know what role MDMA may play in PTSD treatment, but the encouraging results of this pilot study suggest that it may play an important role in treating patients who have not responded to other treatments,” study author Michael C. Mithoefer, MD, a psychiatrist in Mount Pleasant, S.C., says in an email interview. “More research is needed to see if these results can be replicated elsewhere and in larger studies.”

    Exactly how MDMA helps treat the symptoms of PTSD is not clear. “We are a long way from having a complete answer to that question,” Mithoefer says. In general, PTSD therapy involves revisiting trauma. “Often people with PTSD have difficulty revisiting their trauma without either being overwhelmed by emotions or being emotionally detached,” he says. Both of these can become obstacles to successful treatment, but “our impression is that MDMA catalyzes therapy by helping to overcome those obstacles.”

    Safety Matters

    The drug appeared safe in the new study. That said, the jury is still out on the risks of MDMA.

    “Our research is aimed at establishing the risk/benefit ratio, which appears favorable in this early study, but further research is needed to establish this,” Mithoefer says. “MDMA elevates blood pressure and heart rate, which can be a risk to people with cardiovascular disease.” MDMA has also been linked to death from heat stroke or excessive fluid in the substance of the brain (cerebral edema).

    “There can also be psychological risks, which is why our study used MDMA doses only under direct supervision of therapists with close follow-up in non-drug therapy sessions to help integrate the experience and process any emotions and insights that arose from the sessions,” he says.

    The next step is to study this treatment on veterans with PTSD, using three different doses of MDMA rather than placebo.

    Ecstasy's Role in Treating PTSD

    “It is an interesting approach, and this is a well-conducted clinical trial showing positive effects,” says Charles R. Marmar, MD, chair of psychiatry at the New York University Langone Medical Center in New York City. “MDMA appears to be reasonably safe and effective and requires more trials."

    Even if further research validates these findings, this treatment would not be for everyone with PTSD, he says. People with a history of addiction and people with a family or personal history of serious mental illness would not be candidates for this therapy. This drug increases risk of psychotic-like symptoms in people who are vulnerable.

    But “the fact of the matter is that these are difficult-to-treat patients, so having another tool in the armamentarium would be helpful,” Marmar says. “Assuming it is done under highly professional conditions and patients didn't have history of abuse, there is no reason to believe it would be dangerous - yet.

    “We need more work to find out what the risks are,” he says.

    Still, Harriet deWit, PhD a professor of psychiatry and behavioral neuroscience at the University of Chicago, says that “the results were quite dramatic and it is proof of concept and very good early evidence.”

    But “we have to be careful that somebody doesn’t take this and say ‘we can use the drug at any time, in any circumstance in higher doses,’” she says.

    By Denise Mann
    WebMD Health News

    Reviewed by Laura J. Martin, MD

  2. RaverHippie
    Ecstasy Shows Promise in Relieving PTSD

    Ecstasy Shows Promise in Relieving PTSD
    Ecstasy has always been an unusual drug of abuse. Its high is complicated: there is euphoria, certainly, and an amphetamine kick. But because ecstasy causes the brain to flood with serotonin and oxytocin — two chemicals heavily implicated in emotion — it has the atypical ability to precipitate both introspection and sociability. Despite the dreadful, serotonin-depleted ecstasy hangovers known as "suicide Tuesdays," users have for many years promoted the drug's salutary features. Still, are we ready for ecstasy to be thought of as medicine?

    On July 19, the Journal of Psychopharmacology reported the results of the first randomized, controlled trial of ecstasy, which is known to chemists as 3,4-methylenedioxymethamphetamine, or MDMA. The study's authors — led by Dr. Michael Mithoefer, a South Carolina psychiatrist — gave MDMA or a placebo to patients with posttraumatic stress disorder (PTSD) whose condition had not been alleviated by any standard combination of psychotherapy and antidepressants. The new paper showed that ecstasy is not only safe when administered in controlled settings but also remarkably effective in treating PTSD in conjunction with psychotherapy. (See the top 10 medical breakthroughs of 2009.)

    Given the controversial nature of their study, the authors write in an all-business tone — the word ecstasy does not appear anywhere in the article. They begin by noting that PTSD is a serious mental-health problem — it is diagnosed in roughly 8% of Americans and as many as 1 in 5 U.S. servicemen and -women returning from Afghanistan and Iraq — and that we have little clue about how to treat it.

    An esteemed psychologist specializing in PTSD, Edna Foa, has noted that government-approved drugs like Paxil and Zoloft are effective in only about 20% of PTSD patients. Talk treatment known as cognitive behavioral therapy (CBT) works much better — a majority of PTSD patients show some improvement after a course of CBT sessions. But roughly one-quarter of PTSD patients drop out of CBT, partly because it requires them to discuss searingly painful events.

    The basis for using ecstasy in PTSD treatment is that the drug dramatically reduces immediate anxieties, allowing the user to open up emotionally, even as the body and brain are energized by the drug. Clubgoers like this effect because it allows them to party for hours. But Mithoefer's team wondered if this sensation could be harnessed for therapy.

    It's not a new idea. Before the federal government made ecstasy illegal in 1985, the drug was used among a small but enthusiastic group of progressive psychotherapists around the world. (I discuss its history in this 2000 TIME cover story.) But the Journal of Psychopharmacology paper marks the first time the FDA and the Drug Enforcement Administration have allowed a scientific study on MDMA. It took the authors more than a decade to get approval for the research, which began in 2004.

    Because of budget and time restraints, only 20 participants could be recruited, which is the study's biggest flaw — it's very small. Still, the most rigorous scientific methods were applied: the volunteers were randomized to receive either a placebo or MDMA. Those who administered the pills did not know whether they were giving the drug or the placebo. The participants were housed overnight after they took their pill, and they had to speak with a nurse every day for a week afterward. More important, they had to undergo continuous psychotherapy, with sessions before, during and after two separate MDMA experiences. Emergency physicians were on hand in case anyone had an adverse reaction.

    No one had an adverse reaction, even though all participants were difficult cases — long-term PTSD patients whose anxiety had not been alleviated by any traditional treatment method. These were patients prone to frequent anxiety attacks, and yet the MDMA caused none to panic.

    Ten of the 12 patients (83%) who were given MDMA no longer showed PTSD symptoms after two months of treatment — in fact, they didn't even qualify as PTSD patients any more. Only two of the eight patients in the placebo group showed such improvement. Three MDMA patients who had told researchers they could not work because of their PTSD returned to their jobs after their MDMA sessions.

    The results are remarkable — any pharmaceutical company would be thrilled with an 83% recovery rate at two months. But the scientists are appropriately cautious about what it means. The major problem, again, is the small sample size, although most so-called Phase II trials, like this one, aren't very large. (Phase I trials show that a drug is safe; Phase II trials show that a drug is effective; Phase III trials — the final test before a drug can be put on the market — reconfirm safety and effectiveness in a very large, diverse sample.)

    Another problem may be related to the placebo response: the patients who did well on MDMA knew they were involved in a study of a drug so potent that the government had outlawed it. They probably expected to feel better, and that expectation can be powerful.

    Still, the new paper represents the first time in a generation that psychedelic drugs have been taken seriously as treatment. And it offers a new hope for patients whose PTSD may require an unusual approach.

    By John Cloud Tuesday, Jul. 20, 2010


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