FDA Okays New Trials on the Effectiveness of Treating PTSD with Ecstasy

  1. Beenthere2Hippie
    View attachment 53209 CHARLESTON, S.C. — After three tours in Iraq and Afghanistan, C. J. Hardin wound up hiding from the world in a backwoods cabin in North Carolina. Divorced, alcoholic and at times suicidal, he had tried almost all the accepted treatments for post-traumatic stress disorder: psychotherapy, group therapy and nearly a dozen different medications.

    “Nothing worked for me, so I put aside the idea that I could get better,” said Mr. Hardin, 37. “I just pretty much became a hermit in my cabin and never went out.”

    Then, in 2013, he joined a small drug trial testing whether PTSD could be treated with MDMA, the illegal party drug better known as Ecstasy.

    “It changed my life,” he said in a recent interview in the bright, airy living room of the suburban ranch house here, where he now lives while going to college and working as an airplane mechanic. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.”

    Based on promising results like Mr. Hardin’s, the Food and Drug Administration gave permission Tuesday for large-scale, Phase 3 clinical trials of the drug — a final step before the possible approval of Ecstasy as a prescription drug.

    If successful, the trials could turn an illicit street substance into a potent treatment for PTSD.

    Through a spokeswoman, the F.D.A. declined to comment, citing regulations that prohibit disclosing information about drugs that are being developed.

    “I’m cautious but hopeful,” said Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine, a leading PTSD researcher who was not involved in the study. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”

    But he expressed concern about the potential for abuse. “It’s a feel-good drug, and we know people are prone to abuse it,” he said. “Prolonged use can lead to serious damage to the brain.”

    The Multidisciplinary Association for Psychedelic Studies, a small nonprofit created in 1985 to advocate the legal medical use of MDMA, LSD, marijuana and other banned drugs, sponsored six Phase 2 studies treating a total of 130 PTSD patients with the stimulant. It will also fund the Phase 3 research, which will include at least 230 patients.

    Two trials here in Charleston focused on treating combat veterans, sexual assault victims, and police and firefighters with PTSD who had not responded to traditional prescription drugs or psychotherapy. Patients had, on average, struggled with symptoms for 17 years.

    View attachment 53210 After three doses of MDMA administered under a psychiatrist’s guidance, the patients reported a 56 percent decrease of severity of symptoms on average, one study found. By the end of the study, two-thirds no longer met the criteria for having PTSD. Follow-up examinations found that improvements lasted more than a year after therapy.

    “We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” said Dr. Michael C. Mithoefer, the psychiatrist who conducted the trials here. “We think it works as a catalyst that speeds the natural healing process.”

    The researchers are so optimistic that they have applied for so-called breakthrough therapy status with the Food and Drug Administration, which would speed the approval process. If approved, the drug could be available by 2021.

    Under the researchers’ proposal for approval, the drug would be used a limited number of times in the presence of trained psychotherapists as part of a broader course of therapy. But even in those controlled circumstances, some scientists worry that approval as a therapy could encourage more illegal recreational use.

    “It sends the message that this drug will help you solve your problems, when often it just creates problems,” said Andrew Parrott, a psychologist at Swansea University in Wales who has studied the brains of chronic Ecstasy users. “This is a messy drug we know can do damage.”

    Allowing doctors to administer the drug to treat a disorder, he warned, could inadvertently lead to a wave of abuse similar to the current opioid crisis.

    During initial studies, patients went through 12 weeks of psychotherapy, including three eight-hour sessions in which they took MDMA. During the sessions, they lay on a futon amid candles and fresh flowers, listening to soothing music.

    Dr. Mithoefer and his wife, Ann Mithoefer, and often their portly terrier mix, Flynn, sat with each patient, guiding them through traumatic memories.

    “The medicine allows them to look at things from a different place and reclassify them,” said Ms. Mithoefer, a psychiatric nurse. “Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions.”

    Research has shown that the drug causes the brain to release a flood of hormones and neurotransmitters that evoke feelings of trust, love and well-being, while also muting fear and negative emotional memories that can be overpowering in patients with post-traumatic stress disorder. Patients say the drug gave them heightened clarity and ability to address their problems.

    For years after his combat deployments, Mr. Hardin said he was sleepless and on edge. His dreams were marked with explosions and death. The Army gave him sleeping pills and antidepressants. When they didn’t work, he turned to alcohol and began withdrawing from the world.

    Since the trial, he has gone back to school and remarried.

    The chemist Alexander Shulgin first realized the euphoria-inducing traits of MDMA in the 1970s, and introduced it to psychologists he knew. Under the nickname Adam, thousands of psychologists began to use it as an aid for therapy sessions. Some researchers at the time thought the drug could be helpful for anxiety disorders, including PTSD, but before formal clinical trails could start, Adam spread to dance clubs and college campuses under the name Ecstasy, and in 1985, the Drug Enforcement Administration made it a Schedule 1 drug, barring all legal use.

    Since then, the number of people seeking treatment for PTSD has exploded and psychiatry has struggled to keep pace. Two drugs approved for treating the disorder worked only mildly better than placebos in trials. Current psychotherapy approaches are often slow and many patients drop out when they don’t see results. Studies have shown combat veterans are particularly hard to treat.

    In interviews, study participants said MDMA therapy had not only helped them with painful memories, but also had helped them stop abusing alcohol and other drugs and put their lives back together.

    On a recent evening, Edward Thompson, a former firefighter, tucked his twin 4-year-old girls into bed, turned on their night light, then joined his wife at a backyard fire.

    “If it weren’t for MDMA … ” he said.

    “He’d be dead,” his wife, Laura, finished.

    They both nodded.

    Years of responding to gory accidents left Mr. Thompson, 30, in a near constant state of panic that he had tried to numb with alcohol and prescription opiates and benzodiazepines.

    By 2015, efforts at therapy had failed, and so had several family interventions. His wife had left with their children, and he was considering jumping in front of a bus.
    A member of a conservative Anglican church, Mr. Thompson had never used illegal drugs. But he was struggling with addiction from his prescription drugs, so he at first rejected a suggestion by his therapist that he enter the study. “In the end, I was out of choices,” he said.

    Three sessions with the drug gave him the clarity, he said, to identify his problems and begin to work through them. He does not wish to take the drug again.

    “It gave me my life back, but it wasn’t a party drug,” he said. “It was a lot of work.”

    By Dave Phillips - The NY Times/Nov. 29, 2016
    Photos: Travis Dove, nyt
    Newshawk Crew

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    Author Bio

    BT2H is a retired news editor and writer from the NYC area who, for health reasons, retired to a southern US state early, and where BT2H continues to write and to post drug-related news to DF.


  1. mer kaba
    This article has made my day. MDMA has for me has broken down so many walls, I can only imagine how useful it'll be for these poor soldiers in 'service' to this Country.
  2. Player11769
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    He has to realize that it can't be a long term solution it will also be a therapeutic dose

    But this is good news street MDMA is never pure and is one of the big killers
  3. foremoreaddict
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    It certainly can be a long term solution with just one dose. PTSD can be a long term problem with just one overwhelming experience.

    Though MDMA, especially sold as exstacy tablets, have a bad reputation for being impure it would not be ranked anywhere near as deadly as drugs like alcohol or heroin.
  4. Player11769
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    It would be years before the FDA would consider using it long term many studies must be done first and might not be as deadly but it can kill you just like any other drug in its pure form and they don't give recreational dose's it's therapeutic dose's so people wouldn't be bobbing about all jolly and hallucinating unless they abused it and PTSD can have multiple reasons you can't just pin it to one experience because one person with PTSD had it

    If it works then good luck them because it will be a lot of testing and studying to do before the federal government and the FDA approve if it will help then they will weigh the pros and cons then if the pros outweigh the cons human trials will begin this process will take at least 10 years before a human trials faze maybe longer because long term studies will need to be done and who knows there might be another drug that comes out which is better at controlling emotional states and moods which there are already loads of

    I personally despise the drug it killed two of my friends who died from dehydration which is a direct symptom of MDMA overdose the other one was killed by a dodgy one so can't really blame it

    Still far more promising new SSRIs and NA anti depressants coming out but the FDA don't take chances and will make the right decision who knows I might be wrong no one knows for sure that's a fact anyway
  5. Leeloo
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    It s a great step I think. MDMA helped me (as a psychiatric patient), too, but I didnt realize how much. I took time. I could feel that time, how am I emotionally flat and realize I didnt feel real love and how my love, that I try or want to feel, is actually a fake. That is important information, too.
  6. Player11769
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    Also I just read up that it can cause memory problems and motor function problems with chronic users so basically it damages the brain over time

    If it were to be made legal it would likely be like valium and only used for short term before moving on to therapy or another drug Even then people would still abuse and its because of idiots that do abuse prescription drugs that it takes so long and why so many new drugs are rejected
  7. Player11769
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    If therapeutic dose's do turn out to help people then I'm all in for it but it can't be a long term solution because it damages the brain overtime also those would have been recreational dose's you were taking medical dosing would deinitely not include any of the hallucinating or delusionns on purpose it would be a therapeutic dose like when you're in hospital after surgery they don't get you morphine out your mind they give you enough to dull the pain

    I hope it does become prescription legal for people who need it but I definitely think it would be a short term use before moving to therapy also I fear it would have a high abuse chance and it wouldn't stop criminals making MDMA
  8. Leeloo
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    Yes, it s short-term solution. That s why it s called drus-assisted psychotherapy, because the therapy is needed there. But it can help a lot.
  9. Player11769
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    Remains to be seen if therapeutic dose's will have an effect
  10. Potter
    Re: F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients

    Player11769 What are you going on about? Ten years before trials? No, they are starting them now. Mushroom trials have already been going on.

    No, they aren't meant to be taken daily for long or short term use, where would you get such an idea? They do in fact use moderate to heavy doses.
    There is quite a large body of evidence for psychedelic therapy, your doubts are pretty misguided, but looking over your posts, you seem to regularly miss the point.
  11. ladywolf2012
    As an old psychotherapist (born in 1950), I participated in some of the earlier legal use of MDMA for dealing with severe psychiatric issues like PTSD. After public hearings in congress, the drug was banned, allegedly for "one year" (yeah, right) and made a schedule 1 substance in 1985. Gee, congress, thanks...

    The pure form of the drug, with no toxic additives like methamphetamine added to it, is certainly not as dangerous as what has been sold as the street forms of Ecstasy ever since 1985. Yes, there are risks involved in taking the drug often, such as Serotonin Syndrome if MDMA is mixed with the wrong drugs like SSRI or SNRI antidepressants (and many more). The come-down is still kind of harsh even with the pharmaceutically pure form of the drug, and should be monitored by a professional. There are medications which can help to ease up the harshness of the come-down.

    My own experience in using the drug therapeutically was as both a client and a therapist. As a client, I made enormous strides in working with my own PTSD and suicidal depression by using MDMA as rarely as every four months or so. The changes that my therapist helped me to make were permanent and have lasted a lifetime, so far. When I had the honor of working with a client who was on the drug, I found that very deep psychological material could be handled pretty quickly and easily on MDMA, because when one is on the "real" drug, all sense of fear and tension disappears, and is replaced by an overwhelming feeling of safety and openness to change and growth.

    In the 70s and 80s, most of us who took it considered it to be a kind of sacrament. My personal friends and colleagues never abused it. Instead, we tended to be extremely cognizant of the power of the drug, and to limit our use to, say, once every few months. There was NO feeling of addiction or even of habituation, not really. Remember, this was the pharmaceutically pure drug that had no toxic, addictive additives. I myself tended to alternate it with mushrooms and LSD, and to take each one only once a year or so.

    So I am all for the re-introduction of MDMA as a therapeutic tool. That it is also one of the most exquisite of mind/body feelings that one can have is also undeniable. A sensitive and well-trained therapist or doctor will know that, and permit their client or patient to enjoy the feelings as well as do some valuable psychological work while on it.

    I never imagined that in my lifetime the FDA would reconsider their stance on this drug, so I am pretty astonished and curious to see what happens next!
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