Psychedelic Pioneer Rick Doblin On FDA Trials Of MDMA: Most Important Reality Check Of MAPS’ 34-Year History


It was over three decades ago that Rick Doblin, PhD., first began openly advocating for psychedelics as a potential treatment for emotional trauma. At the time, it was a bit of a hard sell to an American public caught in the throes of the War on Drugs, heavily hyped since the early 1970s. It was also a great challenge to demonstrate to government officials the positive effects that a drug like MDMA (known largely as the club drug ecstasy) was having on people suffering from emotional illnesses, including posttraumatic stress disorder (PTSD).

At the time, MDMA had an incredibly positive track record that policymakers chose to overlook. Before MDMA was designated as an illegal Schedule 1 substance in the mid-1980s, it had shown great effectiveness as a treatment used by psychiatrists and psychotherapists to improve the success of psychotherapy. But the dark decades of the War on Drugs closeted any potential use of the substance for patients.

In 1986, Doblin founded the Multidisciplinary Association for Psychedelic Studies (MAPS) to ensure that MDMA continued to be studied by serious researchers. From the beginning, Doblin recognized that scientific consensus would be the likeliest route to get MDMA therapy legalized and out to the public. That meant the best shot was clinical trials with the U.S. Food and Drug Administration (FDA), just like any other doctor-prescribed drug on the market, be it an anti-depressant or heart medication. Science would ultimately decide if it was safe and effective for patients.

Fast forward three and a half decades to 2020, and Doblin’s continued relentless advancement for the cause of MDMA-assisted psychotherapy for PTSD. Having to date raised over $80 million from donors over its 34-year run, MAPS has now successfully ushered MDMA-assisted psychotherapy through demanding Phase 1 and Phase 2 FDA clinical trials, proving its viability as a potential treatment for PTSD. Currently in Phase 3 trials, MDMA-assisted psychotherapy is in its final drive towards legitimacy as a legal treatment. And a recent examination has increased the likelihood that the FDA will approve MDMA for legal doctor-prescribed therapist-supervised use.

Phase 3 trials are a notoriously rigorous stage where drug development companies must confirm and expand on safety and effectiveness results gleaned from Phase 1 and 2 trials. In fact, a recent interim analysis conducted by an independent data monitoring committee (DMC) – a third-party confirmation performed in agreement with the FDA – has reviewed MAPS’s early Phase 3 data at a time when 60% of the subjects had completed the study. That analysis has revealed a 90% or greater probability that the trial will produce statistically significant results when all participants have been treated. In plain English: MAPS is well on course to meet the FDA’s efficacy requirements for approval as a legal prescription drug.

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