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

    by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> 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) <reversethis-{gro ... s} {ta} {noykat}> 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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