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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: 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: 1) by ants_in_pants on Wednesday August 30 2017, @08:35PM (2 children)

    by ants_in_pants (6665) on Wednesday August 30 2017, @08:35PM (#561700)

    LSD is one of the most difficult drugs to synthesize. The only harder one I can think of is psilocybin. It takes some pretty expensive lab equipment.

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