FDA May Soon Allow MDMA Prescriptions for PTSD

Authored by reason.com and submitted by EinarrPorketill
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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.

EinarrPorketill on July 31st, 2018 at 22:11 UTC »

This very important research was conducted by the non-profit organization MAPS (maps.org). MDMA is not patentable, so this is truly in the public's benefit. This research is about MDMA-assisted psychotherapy; it's not a drug that people take home and take regularly. The MDMA allows people to access and process traumatic memories much easier, which often greatly improves PTSD symptoms long after the MDMA wears off. This is an incredibly revolutionary approach to psychiatry.

If you think this research is important, please consider donating to them to fund their further studies. I personally believe this is only the beginning to the therapeutic potential to certain psychedelic drugs, and they need to conduct further research to scientifically prove things that many people that take these drugs know intuitively.

Here's a good documentary on MDMA for PTSD and marriage counseling: https://www.youtube.com/watch?v=M2UgmXEgoLA

throwaway34831 on July 31st, 2018 at 21:17 UTC »

I was at the MAPS conference in Pittsburgh and got to hear Dr. Rick Doblin, whose running the research and taking MDMA through phase 3 drug trials in september, talk about the research and even show a video of one of the patients undergoing the therapy. They're opening up early access sites since the law says if there is an experimental drug that might help your condition you can request to be included in the phase 3 trial! Reach out to them through www.maps.org, they're popping up all over the country.

In other news, because drug patents are treatment specific, MAPS will have sole distribution rights for MDMA for treating severe PTSD. According to Dr. Doblin, much of the proceeds will be funneled back into MAPS to continue research and advocating for other psychedelic therapies. His estimate is by 2020 or 2021 MDMA will be available for severe PTSD by prescription.

Last point, though MDMA feels great for most of us, those with PTSD reportedly say "I have no fuckin clue why they call it 'ecstacy'". The experience is really painful for them to undergo, by no means is it similar to someone without PTSD's experience.

EDIT: worth mentioning. Dr. Dobson also mentioned applying for special considerations. Pretty high time cost so most from big pharma don't do it. It means for MDMA, that the FDA is contractually obligated to approve its use if the phase 3 trials show similar results to all previous studies. Also, the he sued the the DEA and won to get this research.

TLDR:

Phase 3 drug trials start in September. Early access sites found at: www.maps.org/research/mdma Legal prescriptions by 2021. Dr. Rick Doblin is a badass.

HeadsOfLeviathan on July 31st, 2018 at 19:56 UTC »

Yeah the high is fantastic and almost impossible to feel sad...but that comedown though.