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Second MAPS Phase 3 Clinical Trial Confirms Positive MDMA Results

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A growing body of research has revealed that psychedelic drugs such as psilocybin and MDMA have the potential to alleviate a variety of mental illnesses. Decades of federal prohibition made it nigh impossible for scientists to research the possible medical applications of psychedelics, but there has been an upsurge in psychedelic research over the past couple of years.

Early results have been extremely encouraging, with clinical studies finding that psychedelics can cause profound changes in mental health and perception when paired with psychotherapy.

The Multidisciplinary Association For Psychedelic Studies (MAPS) is at the helm of the first-ever phase 3 clinical trial studying the potential of using MDMA-assisted psychotherapy to treat PTSD. In mid-2021, MAPS revealed that the phase 3 trial had produced promising results and showed that MDMA could be used safely and effectively in PTSD treatment alongside psychotherapy. It was, and still is, the largest and most robust clinical trial into the efficacy of MDMA as a PTSD treatment to date.

Recently, MAPS announced that it had completed the second part of a phase 3 clinical trial and confirmed the positive results produced in the first part of the trial. The results from the first trial had been historic in many ways, and the entire psychiatric industry had been waiting with bated breath for the second part of the study. The confirmation of prior promising results puts MAPS one step closer to receiving official approval for an MDMA treatment for post-traumatic stress disorder.

If the third and final part of the study confirms the results from the prior two parts, MAPS could receive FDA approval.

Even though the announcement from MAPS did not divulge key details, the information provided showed that MAPS is confident in the patient outcomes of its trial. Called MAPP2, the second phase 3 trial of MDMA-assisted psychotherapy involved 104 patients living with PTSD.

The participants were treated with either a placebo with therapy or MDMA-assisted psychotherapy. As with the first part of the study, the second phase 3 trial found that MDMA-assisted therapy could alleviate PTSD symptoms without causing adverse side effects in patients. The revelation from MAPS is a major milestone for the relatively young field of psychedelic-assisted therapy.

Although early results have been extremely encouraging, there has been a concerted absence of solid data from clinical trials on the efficacy of psychedelics as mental health treatments. MAPP2 has provided much-needed evidence on the safety and efficiency of MDMA in the treatment of PTSD.

MAPS will publish the full data from the MAPP2 later this year in a peer-reviewed journal.

The success of the trials being conducted by MAPS will positively rub off on other industry actors such as Field Trip Health Ltd. (OTC: FTHWF) (TSX: FTHW) since the public will have a concrete example to refer to when assessing the viability of investing in psychedelics stocks.

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