FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD

in #science6 years ago (edited)

Treating PTSD with MDMA-Assisted Psychotherapy

Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and education organization that develops medical, legal and cultural contexts for psychedelics and marijuana. The main focus of MAPS research is MDMA-assisted psychotherapy for PTSD, but several MAPS studies have been done for other conditions. MDMA-assisted psychotherapy can help repair psychological and emotional damage caused by sexual assault, war, violent crime and other trauma.

Program of MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder (PTSD)

MDMA is not the same thing as "ecstasy" or "molly". Substances sold in the street under these names may contain MDMA, but also frequently contain unknown and / or dangerous adulterants. In laboratory studies, pure MDMA has been shown to be safe enough for human consumption when taken a limited number of times at moderate doses. The highest priority project is funding clinical trials of methylenedioxymethamphetamine (MDMA) as a psychotherapy aid for the treatment of post-traumatic stress disorder (PTSD). Preliminary studies have shown that MDMA, combined with psychotherapy, can help people overcome PTSD or even other disorders. MDMA is known to increase feelings of trust and compassion towards others, which could be an ideal complement to psychotherapy for PTSD.

MDMA-assisted psychotherapy can help repair psychological and emotional damage caused by sexual assault, war, violent crime and other trauma. MAPS is also studying MDMA-assisted therapy for autistic adults with social anxiety and MDMA-assisted psychotherapy for people with anxiety. In MDMA-assisted psychotherapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for years, and sometimes forever.

MAPS has launched a $ 26.7 million plan for an MDMA processor in an FDA-approved drug (Food and Drug Administration) by 2021 and is currently the only organization in the world to fund clinical trials of psychotherapy-assisted psychotherapy. MDMA. For-profit pharmaceutical companies are not obligated by the development of MDMA as a drug for the MDMA patent and expired. The idea of using MDMA to help therapies of all kinds for a specific clinical indication for a long time in the public domain.

Scientific Presentations

As the research of MAPS has developed, the interest of the scientific community is increased. The discussion is no longer dominated by sensationalism about "ecstasy" and raves, or misinformation about toxicity. As our results have been published in a respected and peer-reviewed journal, and we continue to speak at medical conferences, MDMA-assisted psychotherapy is increasingly seen as a promising area of ​​research to solve a problem. major public health. MDMA is increasingly being discussed as a drug that, like any other medicine or procedure used in medicine, has potential risks and benefits that need to be carefully evaluated. MAPS psychedelic sciences conferences have been well attended and we have been invited to present the results of our research at numerous conferences, including the Royal College of Psychiatrists in England, the American Psychological Association, the European College of Neuropsychopharmacology, the International Society for Traumatic Stress Studies and others.

The most recent sign of the growing interest of the psychiatric community has been the inclusion of our three-hour symposium on psychedelic research at the 2015 Annual Meeting of the American Psychiatric Association in Toronto, Canada. Charlie Grob from UCLA and I talked about clinical research on MDMA. Roland Griffiths and Matt Johnson of Johns Hopkins and Michael Bogenschutz of the University of New Mexico spoke about clinical research on psilocybin. The symposium was well received with thoughtful and enthusiastic discussions at the end and a number of psychiatrists and psychologists in training or who recently completed their training expressed their passion for orienting their careers towards this type of work.

MAPS is recruiting subjects for clinical trials. Please check back periodically to see if we are in need of new subjects for other studies. Only sites in the United States can participate in the FDA Extended Access Program. Qualified candidates will have a team of health care providers, a physician and an appropriate institution to conduct MDMA-assisted psychotherapy in accordance with Schedule 1 regulations with regulatory approval and under the supervision of MPBC

More information about MAPS-sponsored clinical trials, as well as other ongoing clinical trials in the U.S. and around the world, can be found at https://clinicaltrials.gov/

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