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posted by cmn32480 on Wednesday August 30 2017, @01:38PM   Printer-friendly
from the and-the-side-effects-are.... dept.

The U.S. Food and Drug Administration has given its approval for Phase 3 trials to treat participants with PTSD using MDMA ("ecstacy"):

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.

MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.

The first Phase 3 trial (MAPP1), "A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder," will begin enrolling subjects in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall.

[...] The Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

In MAPS' completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.

Also at ScienceAlert, the Washington Post, and Science Magazine:

Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.


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  • (Score: 1, Interesting) by Anonymous Coward on Wednesday August 30 2017, @01:44PM (14 children)

    by Anonymous Coward on Wednesday August 30 2017, @01:44PM (#561493)

    What will they re-invent next? Maybe therapy combined with LSD as successfully trialed (by Tim Leary and others) in the early 1960s?

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  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:48PM (1 child)

    by Anonymous Coward on Wednesday August 30 2017, @01:48PM (#561494)

    nah, it'll go mainstream and be used to make more people completely delusional. see the 'news' on doping populations with oxy and watch 'brave new world'; things you liked used against you. oh yawn.

    • (Score: 2, Insightful) by Anonymous Coward on Wednesday August 30 2017, @02:22PM

      by Anonymous Coward on Wednesday August 30 2017, @02:22PM (#561509)

      It's not mainstream enough until kids can buy it out of a vending machine just like caffeine.

  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:55PM (4 children)

    by Anonymous Coward on Wednesday August 30 2017, @01:55PM (#561499)

    Too lazy to cite, but I vaguely recall some research somewhere indicating that symptoms of depression appeared immediately following administration of LSD. Given how much it messes with serotonin, it sounded reasonable. That will likely put a damper on any future research on LSD as a kind of therapy, at least without some kind of pairing with SSRIs of some sort after the "session".

    • (Score: 3, Informative) by Scottingham on Wednesday August 30 2017, @02:42PM

      by Scottingham (5593) on Wednesday August 30 2017, @02:42PM (#561518)

      That's odd, I've heard the exact opposite with LSD. Though I too am too lazy to cite.

      Are you perhaps confusing it with the after-effects of MDMA? That is definitely associated, especially in an uncontrolled setting with an unknown dosage, symptoms of depression.

    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @03:25PM (1 child)

      by Anonymous Coward on Wednesday August 30 2017, @03:25PM (#561532)

      Too lazy to cite, but I vaguely felt the symptoms of thinking you're a dumbass set in after reading your comment.

      • (Score: 2) by edIII on Wednesday August 30 2017, @09:26PM

        by edIII (791) on Wednesday August 30 2017, @09:26PM (#561739)

        Oh no. I think it's contagious.

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    • (Score: 3, Interesting) by takyon on Wednesday August 30 2017, @04:07PM

      by takyon (881) <takyonNO@SPAMsoylentnews.org> on Wednesday August 30 2017, @04:07PM (#561548) Journal

      You're thinking of MDMA, the very drug this story is about. To counter that, you take 5-HTP [wikipedia.org] to restore serotonin levels.

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  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @01:58PM (3 children)

    by Anonymous Coward on Wednesday August 30 2017, @01:58PM (#561502)

    In the 1980s, Leary became fascinated by computers, the Internet, and virtual reality. Leary proclaimed that "the PC is the LSD of the 1990s" and admonished bohemians to "turn on, boot up, jack in".

    Radical, man! What's his github, and I want to fork his repo.

    • (Score: 3, Interesting) by RamiK on Wednesday August 30 2017, @02:21PM (2 children)

      by RamiK (1813) on Wednesday August 30 2017, @02:21PM (#561508)

      This was years before personal computers. Not only was the hardware needed to run Unix too expensive to be within an individual's reach, but nobody imagined that would change in the foreseeable future. So Unix machines were only available by the grace of big organizations with big budgets: corporations, universities, government agencies. But use of these minicomputers was less regulated than the even-bigger mainframes, and Unix development rapidly took on a countercultural air. It was the early 1970s; the pioneering Unix programmers were shaggy hippies and hippie-wannabes. They delighted in playing with an operating system that not only offered them fascinating challenges at the leading edge of computer science, but also subverted all the technical assumptions and business practices that went with Big Computing. Card punches, COBOL, business suits, and batch IBM mainframes were the despised old wave; Unix hackers reveled in the sense that they were simultaneously building the future and flipping a finger at the system.

      http://www.faqs.org/docs/artu/ch02s01.html [faqs.org]

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      • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @02:35PM (1 child)

        by Anonymous Coward on Wednesday August 30 2017, @02:35PM (#561511)

        Linux is the establishment and systemd is the flipping finger. Countercultural enough for you?

        • (Score: 3, Insightful) by Anonymous Coward on Wednesday August 30 2017, @04:23PM

          by Anonymous Coward on Wednesday August 30 2017, @04:23PM (#561555)

          I realise that you're being jocular, but:

          honestly, systemd is more like the establishment trying to worm its way into Linux. "It's too hard for the Marketing department guys! Just ... make all that complexity go away! Like Microsoft!"

  • (Score: 2) by takyon on Wednesday August 30 2017, @04:42PM (2 children)

    by takyon (881) <takyonNO@SPAMsoylentnews.org> on Wednesday August 30 2017, @04:42PM (#561566) Journal

    It could be used to treat depression and alcoholism. [theguardian.com]

    It's going to be slow going when it comes to getting any mainstream acceptance of hallucinogens. Many U.S. states and countries have legalized cannabis for medical purposes and that is still sitting on the joke that is Schedule I. LSD is too scary, see headlines like:

    Is marijuana really as dangerous as heroin and LSD? Finally, a welcome legal review [latimes.com]

    Marijuana remains a Schedule 1 drug - just like heroin and LSD - judge rules [dailynews.com]

    Look out for the "heroin and LSD" journalist meme when you read articles like this. You'll start seeing it a lot.

    As we should know by now, LSD is about as far away from dangerous as you can get [ias.org.uk]. Maybe you'll knock something over and get hurt. You probably won't jump out of a window.

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    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @05:31PM (1 child)

      by Anonymous Coward on Wednesday August 30 2017, @05:31PM (#561594)

      As well it should. The burden of proof here is on the proponents to prove that the substance is safe enough and effective enough for a given use. We're long past the point where there was enough need for new treatments and a lack of resources for studying them.

      Ultimately, the people who claim without research to back it that these things are safe and effective are just as bad as the people who think we should ban all use, including research, without a body of evidence to point to.

      Alcoholism and such are serious issues, but they're also not completely without treatment available either.

      • (Score: 5, Informative) by takyon on Wednesday August 30 2017, @06:04PM

        by takyon (881) <takyonNO@SPAMsoylentnews.org> on Wednesday August 30 2017, @06:04PM (#561614) Journal

        Schedule I is a research killer. [soylentnews.org]

        MAPS has been working with MDMA, LSD, psilocybin, etc. Very slowly. Because of the barriers to research that come with being on Schedule I. There have already been studies that have found evidence that LSD can be used as a treatment. Safety of LSD is well established.

        The Controlled Substances Act is unscientific. The Schedule I criteria are completely arbitrary.

        "The drug or other substance has a high potential for abuse." = anything they want it to mean.

        "The drug or other substance has no currently accepted medical use in treatment in the United States." = also broad enough to ignore accepted medical uses, and it's difficult to get additional research done because of Schedule I.

        "There is a lack of accepted safety for use of the drug or other substance under medical supervision." = anything they want it to mean.

        The burden of proof is for proponents to prove to the FDA that a drug can be a safe and effective treatment. The DEA and Controlled Substances Act are shit and should be eliminated. It would save money and lives.

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