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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 Snow on Wednesday August 30 2017, @03:17PM (10 children)

    by Snow (1601) on Wednesday August 30 2017, @03:17PM (#561528) Journal

    I did MDMA once. It was at some festival called Shambala in BC.

    It didn't really do anything for me. My wife did some as well and she was fucked up. She started hearing voices and said that everyone was shit-talking her behind her back (they weren't). It lasted for a couple weeks and we went to the doc over it. For like 2 weeks she couldn't even go to the supermarket. Thankfully it went away, but I was really worried for a while.

    It didn't really do anything for me though. I had a very faint headache/pleasure feeling, but nothing crazy. Felt like shit the next day though. Totally drained, both physically and emotionally. It was as if someone drained the life from me. Lasted for a couple days and then things were normal.

    That being said, I would definitely try it again given the right opportunity.

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  • (Score: 2, Funny) by Anonymous Coward on Wednesday August 30 2017, @03:27PM

    by Anonymous Coward on Wednesday August 30 2017, @03:27PM (#561533)

    [quote]That being said, I would definitely try it again given the right opportunity.[/quote]

    "That being said"? That which was said has to be the worst supporting argument I've ever read.

  • (Score: 2) by Gaaark on Wednesday August 30 2017, @04:00PM

    by Gaaark (41) Subscriber Badge on Wednesday August 30 2017, @04:00PM (#561544) Journal

    The only time i smoked pot was in college: a viet nam vet grew his own (so i'm guessing not that strong). Shared a joint with him and 3 others.
    Felt NOTHING.
    He brought over another joint a day later and smoked it with me.
    Nothing.
    The next day, he brought over another with a ball of snot (he said was hash: i'm hoping it was NOT snot, lol) that he put into the joint.
    One puff and i was GONE.

    All i remember is having MAJOR MUNCHIES and eating $20 worth of crap (this would be mid-late 80's where $20 bought a crap load of crap-food: you could buy candies for 1cent).
    Felt awful after.

    That's why i stuck with alcohol.
    Now, gettting off the alcohol as well.

    --
    --- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
  • (Score: 3, Informative) by takyon on Wednesday August 30 2017, @04:29PM (3 children)

    by takyon (881) <takyonNO@SPAMsoylentnews.org> on Wednesday August 30 2017, @04:29PM (#561556) Journal

    MDMA is notorious [hightimes.com] for being faked [stuff.co.nz] or mixed with other shit. That's not propaganda but on the ground reality, which has led to the emergence of testing on the scene at festivals [dancesafe.org]. You really don't know what you and your wife had (unless you really do). This is as good of a reason as any to say "I would definitely try it again given the right opportunity" since might not know if you did it a first time.

    LSD is also easy to fake since at least an order of magnitude more drug than needed can be fit onto a blotter and there are a family of compounds [wikipedia.org] that are very similar to LSD but with different total durations and dosages. It's hard to say that fake means bad here - if Albert Hofmann had synthesized a different chemical first, maybe that would be the drug of the 60s and the LSD molecule would be the unknown mimic drug. Whooooaaa, man. (Feel free to correct me if I'm wrong here. Maybe LSD is easier to synthesize than other similar drugs.)

    I imagine mushrooms or peyote would be hard to fake - as in substitute with another drug. However, my understanding is that peyote [wikipedia.org] takes years to grow from seed to fleshy cactus.

    Cannabis is probably not faked. It could be adulterated or sprayed with pesticides/etc., but the influx of legal options means that there is a lot of (government?) verified weed out there and at least some amount of the supply is "bespoke" organic weed made by people who are health conscious, opportunistic, or both.

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  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @06:23PM (1 child)

    by Anonymous Coward on Wednesday August 30 2017, @06:23PM (#561627)

    She started hearing voices and said that everyone was shit-talking her behind her back (they weren't).

    I'm shit-talking you behind your back, Snow. This is AC talking. I'm always shit-talking you behind your back, Snow.

    • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @07:22PM

      by Anonymous Coward on Wednesday August 30 2017, @07:22PM (#561657)

      You now hear the screaming forever.

  • (Score: 0) by Anonymous Coward on Wednesday August 30 2017, @08:10PM

    by Anonymous Coward on Wednesday August 30 2017, @08:10PM (#561682)

    Apart from the reasons given by takyon, did you even do MDMA ("molly")? It's usually sold as small crystals of clear to brown-tinged colour, while Ecstasy/XTC is sold as pills. The crystal form of "molly" makes it hard as fuck to dose right, you can of course eyeball it by dipping your wet finger in it, but a precision scale is recommended - especially for a first-timer/casual user with low threshold/tolerance.

    Do you have an idea of how much you and your wife took? MDMA, while relatively safe, can be neurotoxic at very high levels. So while you may have gotten a typical effect for a first timer (none), maybe your wife had way too much?

  • (Score: 0) by Anonymous Coward on Thursday August 31 2017, @07:30PM

    by Anonymous Coward on Thursday August 31 2017, @07:30PM (#562264)

    y'all got some bullshit. probably wasn't even X from the symptoms you describe. try to get good shit next time, ffs.