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Qualia Research Institute Question Series: Will MDMA be approved for the treatment of PTSD by 2025?

This is the first in a three-part series of questions suggested by the Qualia Research Institute, with particular thanks to Andrés Gómez Emilsson, whom you can find blogging at the always interesting

Not to be confused with the street drug formulations that (sometimes) contain MDMA along with various adulterants, pure MDMA has long been indicated as effective therapy for a range of conditions. Although the hurdles to a radical reversal in drug policy (MDMA is a Schedule 1 drug in the US, meaning officially speaking, it has no approved therapeutic use) are numerous, there have been a number of positive developments of late.

In 2017, MDMA was designated a "breakthrough therapy". From CBS News:

According to the FDA's website, a designation of "breakthrough therapy" simply means the agency will expedite the review of the drug and potential approval. The status is granted when "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement" over other available therapies.

And in January, the ensuing clinical trials were wrapping up. From Newsweek:

The final round of clinical trials for MDMA assisted psychotherapy is kicking off in Vancouver, leading the way for Canada and the United States to approve the drug for therapeutic use as early as 2021.

The third and final phase of trials gets underway after the Food and Drug Administration (FDA) designated MDMA as a “breakthrough therapy” for post-traumatic stress disorder (PTSD) in August 2017, ensuring that it will work with advocates to complete the last phase quickly.

The results of these trials have been extremely promising, and have spurred renewed interest in the therapy.

Large-scale trials, which will include up to 300 participants at 14 sites, may not be able to replicate the success of previous trials, which were limited to a few dozen patients. But so far, results are encouraging. Nearly all patients saw clinically significant reductions in symptoms, and a majority saw such drastic reductions that they no longer met the criteria for a PTSD diagnosis. In the 12 months after MDMA therapy, PTSD symptoms generally continued to decrease.

Side effects, including anxiety, headache, fatigue, muscle tension and insomnia, were generally minor and limited to the days following the MDMA sessions.

Other researchers, intrigued by the results, are starting their own studies of MDMA therapy, including the Department of Veterans Affairs.

The non-profit Multidisciplinary Association For Psychedelic Studies is funding the trials, and plans to spend nearly $27M in an attempt to gain prescription approval for the drug by 2021.

With the Breakthrough Therapy "fast track" designation on their side, will MAPS succeed? Or will bureaucratic red tape, pharmaceutical industry muscle, deep-seated distrust of psychedelic drugs and/or disappointing test results push the acceptance of MDMA as an FDA-approved treatment for PTSD further into the future?

To resolve positively, a credible media story or a MAPS-affiliated press release must report that MDMA has been approved as a prescription drug in the US prior to January 1st, 2025.

The team at the Qualia Research Institute have generously gotten the ball rolling by providing their own prediction that it is 80% likely the question will resolve positive.


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