By Gabriel García December 20, 2023
A historic milestone in psychedelic research has been reached with the submission by the Multidisciplinary Association for Psychedelic Studies (MAPS) of the first New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
MDMA-assisted therapy consists of a combination of psychotherapy sessions with and without the supervised use of MDMA, a psychoactive substance that has been shown to enhance the effectiveness of psychotherapy by reducing fear and increasing confidence, empathy and introspection. MDMA is not a hallucinogen and does not produce the perceptual distortions typical of other psychedelic substances such as LSD or psilocybin.
The NDA is based on the results of six Phase 2 clinical trials and two Phase 3 clinical trials conducted by MAPS in collaboration with independent investigators in several countries, including the U.S., Canada, Israel and Switzerland. The trials have demonstrated that MDMA-assisted therapy is safe and effective for the treatment of PTSD, especially for those who have not responded to conventional treatments such as antidepressant medications or cognitive behavioral therapy.
The Multidisciplinary Association for Psychedelic Studies is a US non-profit organisation working to increase awareness and understanding of psychedelic substances.
According to MAPS, PTSD affects about 8 million Americans and about 300 million people worldwide, and is associated with an increased risk of suicide, substance abuse, domestic violence, and other mental and physical illnesses. PTSD can be caused by a variety of traumatic events, such as sexual abuse, violence, accidents, combat, natural disasters or terrorism. Many people suffering from PTSD feel isolated, ashamed or misunderstood, and have difficulty trusting others or themselves.
MDMA-assisted therapy offers unprecedented hope for these individuals, allowing them to process their traumas with greater acceptance and compassion, and helping them regain control of their lives. According to MAPS data, 67% of clinical trial participants no longer met diagnostic criteria for PTSD after receiving just two to three sessions of MDMA-assisted therapy, compared to 32% who received psychotherapy alone. In addition, the beneficial effects were maintained for at least one year after treatment.
The NDA filing is the result of more than three decades of research and advocacy by MAPS and its founder and executive director, Rick Doblin, who has dedicated his life to restoring the legitimate medical use of MDMA and other psychedelic substances. MAPS is a non-profit organization that relies primarily on private donations to fund its projects.
Richard Elliot Doblin is an American anti-drug activist and executive, founder and former executive director of the Multidisciplinary Association for Psychedelic Studies.
The FDA granted MDMA Breakthrough Therapy designation in 2017, which accelerated the regulatory process by recognizing its potential to address an unmet medical need. If all goes well, it is possible that FDA approval for prescription use of MDMA-assisted therapy for PTSD could take place around August 2024, with legally required DEA rescheduling to take place within 90 days of FDA approval.
This would mean that MDMA would cease to be an illegal substance classified as having “no accepted medical use” and become a therapeutic tool available under medical supervision. However, this would not mean that MDMA could be used recreationally or outside of the clinical setting, as there are still risks associated with its misuse or unregulated use.
MDMA-assisted therapy is just one part of the psychedelic renaissance that is taking place around the world, with other substances such as psilocybin, LSD, ayahuasca or ibogaine also being investigated for the treatment of various conditions such as depression, anxiety, addictions or existential disorders. These investigations are challenging the prejudices and stigmas surrounding these substances, and are opening new possibilities for healing and personal growth.
If you want to learn more about MDMA-assisted therapy or support the work of MAPS, you can visit their website: https://maps.org/.
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