MDMA

FDA May Soon Allow MDMA Prescriptions for PTSD

MDMA, which was banned by the Drug Enforcement Administration in 1985, could be available by prescription as soon as 2021.

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"I was finally able to process all the dark stuff that happened," Nicholas Blackston, a Marine veteran who served in Iraq, told The New York Times, describing his experience with MDMA-assisted psychotherapy. "I was able to forgive myself. It was like a clean sweep."

MDMA, which was banned by the Drug Enforcement Administration in 1985, could be available by prescription as soon as 2021. The rehabilitation of MDMA, a.k.a. "ecstasy" or "molly," is directly related to the rehabilitation of veterans like Blackston, who participated in a study that confirmed the drug's potential as a catalyst for catharsis.

The trial was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and reported on May 1 in The Lancet Psychiatry. It involved 22 military veterans, three firefighters, and one police officer, all of whom had been diagnosed with chronic post-traumatic stress disorder (PTSD) "resulting from traumatic experience during their service." The researchers, led by Charleston, South Carolina, psychiatrist Michael Mithoefer, randomly assigned the participants to receive 30, 75, or 125 milligrams of MDMA in conjunction with two psychotherapy sessions separated by about a month. The lowest dose served as an "active placebo." Neither the researchers nor the subjects knew who was receiving which amount.

The results were striking. Average scores on the Clinician Administered PTSD Scale (CAPS), which indicates symptom severity, fell by 71 percent in the medium-dose group and 49 percent in the high-dose group, compared to 13 percent in the low-dose group. Sixty-eight percent of the medium- and high-dose subjects no longer met the diagnostic criteria for PTSD, compared to 29 percent of the low-dose subjects.

When people in the control group were given the opportunity to use higher doses of MDMA, they saw additional progress. One year after the MDMA sessions, the mean CAPS score for all subjects was 39, down from 87 at the beginning of the study. The cutoff for a PTSD diagnosis is 50.

These large, persistent improvements reinforce the results of an earlier MAPS-sponsored study that provided MDMA-assisted psychotherapy to crime victims.

The next step is Phase 3 clinical trials, which are the last stage before the Food and Drug Administration decides whether to approve the drug as a treatment for PTSD.

Last August, the agency streamlined that process by deeming MDMA a "breakthrough therapy," meaning it "may demonstrate substantial improvement" over current options. Mithoefer notes that "at least one in two PTSD patients cannot tolerate or do not respond adequately to existing treatments." MAPS plans to start the Phase 3 studies this summer.

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31 responses to “FDA May Soon Allow MDMA Prescriptions for PTSD

  1. This is hardly the first time that something that was banned has been recognized as useful and the ban has been lifted. It’s a recurring theme.

    The fact is that virtually anything can be used effectively or can be abused and cause harm. The government has never been able to grasp this idea, so instead it must periodically re-examine and rescind its bans, but only after untold needless suffering by people who deserved better.

    At this point, who can honestly argue for statism? It’s about giving power to the “right people” ? those don’t exist. It’s always plonkers in charge, let’s face it.

    1. But the government will be there to decide who is worthy of treatment, how many hoops you have to jump through, and what constitutes a good reason for such treatment.

      This will invariably create a black market either for people who don’t trust psychotherapy (see Rosenhan Experiment) or others just looking for a good time.

      This will create a backlash with further restrictions, and we can repeat the whole process over again. See the opioid epidemic.

      1. That may be true eventually but the medical science here is still in the investigation phase. Nobody really knows yet what this means or how to use it.

  2. Who would have thought that Trump would push the Executive Branch to be more lenient on drugs?

    The correct solution is to repeal all drug laws as they are unconstitutional. This piecemeal approach still allows too many people to be pulled into the War on Drugs until they are decriminalized.

    1. Who would have thought this was Trump’s doing?
      Credit where credit is due, but Trump had nothing to do with this. Worship him though you may, he is not the sole source of goodness. Your incessant cheerleading is as tiresome as the negative form of TDS which paints him as the source of all evil. It’s deranged in either case, and in neither case does it accomplish anything.

      1. They’re prescribing Ecstasy specifically for PTDS.

      2. I guess I got a different link.
        A search for the character string ‘trump’ gets no hits in the article I was served.
        If Trump was actually going to push the administration on drugs, a certain schedule one plant, with proven medical uses, would be off the schedule one list, as required by current federal law.

      3. You have TDS knott.

        Suddenly the FDA just decides out of the blue to allow these drugs? Yeah Trump as head of the Executive has no say in this policy.

        1. You haven’t been paying attention. The work leading up to this possible decision pre-dates Trump’s presidency. It’s been reported here and elsewhere and has nothing to do with Trump.
          Just because Trump has a say in policy does not mean that everything that happens happens on his say-so.
          Note that he hasn’t given any evidence of reining in Sessions. Nor made any an nouncements about loosening up on drugs.

          1. Obama was the drug war liberator! Thanks to Obama, all drugs are legal.

            Oh yeah, that never happened.

            Trump feels that he cannot come right out and say that is for legalizing all drugs because most Republicans would not be for that. Trump is not a drug warrior. He seems to be quietly pushing his administration to scale back all the restrictions on drugs.

            Plus, this helps veterans. Even if the media turns on the cause of legalizing drugs because TDS, its helping Vets, so is a risk he can afford.

    2. All drug laws are un Constitutional.

    3. Who would have thought that Trump would push the Executive Branch to be more lenient on drugs?

      Anyone who listened to him 5-30 yrs. ago. But we don’t know whether his thumb on the scale made the difference in the grant of breakthru status.

  3. Sixty-eight percent of the medium- and high-dose subjects no longer met the diagnostic criteria for PTSD

    But what percent were addicted to ecstasy?

    /drug warrior

    1. Big deal. The Harvard Psychedelic Club drastically lowered recidivism by letting Timothy Leary give prison inmates psilocybin. All that did was anger the lard-butt prison guard unions who depend on a Police State for their government paychecks. The offending substance was promptly banned in violation of the First Amendment. (This was before the Libertarian Party formed.) People who vote for Democrat and Gee-Oh-Pee soft machine candidates are endorsing this policy of imprisonment and prohibitionism.

  4. I don’t know much about MDMA. It would be useful if this article listed some of the downside to the drug.

    1. There aren’t all that many, really. Reason has reported well on the subject over the years, though — check through the archives.

    2. Willingness to kiss total strangers.

      1. and dance to electronic music til the break of dawn.

    3. There aren’t any. That’s why it was banned so quickly.

  5. I can’t wait man. My doctor prescribed it for me and was turned down. Maybe this will help.

  6. Keep in mind this is not a daily dose of MDMA. The research is about using MDMA as an adjunct to psychotherapy. The individual is given the drug and then has several therapy sessions spaced apart while under the influence of the drug.

    The original article published in the Lancet seems to be behind a paywall now. Despite the small number of patients it is very promising. The study uses a small dose as an “active control”. Rather than the sugar pill, the controls “feel” something so are more blinded as to whether they have received the placebo. They found a dose dependent relationship. That is the key finding.

    The uncontrolled variable here is what constitutes psychotherapy which is an art as much as science. Different therapists may have differing results. This study somewhat controls for that but needs more statistical power. So they need larger multicenter trials. Those are underway and approved by the FDA.

    The other variable is these were patients refractory to other treatment. What if it were tried in the acute setting right after the trauma occurred. That would be another avenue to approach.

    People might just look at this and think that MDMA is a pill to treat PTSD. It does not say that at all.

  7. I did find this which is speculative. It suggests a neurobiological mechanism for the effect.

    https://tinyurl.com/yd3uzvrp

  8. Ecstasy and Agony… together at last.

    Seriously, though, in my younger, more reckless days I experimented with MDMA recreationally once, and it was great. It was such a great experience in fact, that I never cared to repeat it, which was certainly not the case with many other drugs I um… experimented with quite a bit more extensively back then. I remember thinking during the trip, in a uniquely dissociated way that was very different from any other psychedelic I’d tried, that this drug in a proper medical setting could be a game changer in the treatment of depression.

    Of course I was young, ignorant, and certainly not in a position to pursue or advocate for any kind of legitimate research, and in any case the nanny state quickly rendered the possibility taboo until now, I suppose. In any case, I’m glad to see that my anecdotal fragment of insight at the time might have had some substance to it after all. I hope that it eventually pans out.

  9. I have PTSD. Where do I sign up? Can I bring a friend, who just happens to be a d.j.?

  10. The FDA ses promise in the medical use of MDMA; however, the DEA sees MDMA as a schedule I drug which is highly addictive and without medical use. It will remain illegal until the DEA overlords change the drugs status, no matter what those guys at the FDA say.

  11. Really pain patients can’t get the opioid pain medications they need, but PTSD patients will be able to get ecstasy?

  12. *looks for glowsticks from 1998*

  13. A movie poster for a screen adaptation of Orwell’s 1984 asked: WILL ECSTASY BE A CRIME?
    https://preview.tinyurl.com/ycenfpd5
    Now we wonder if it will be relegalized along with plant leaves, freon, power plants…

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