MAPS, Sunstone Therapies Collaborate on MDMA Therapy Trial

The Multidisciplinary Association for Psychedelics Studies (MAPS) is collaborating with Sunstone Therapies, a company that treats the psychological effects of cancer, to conduct a clinical trial testing the safety and tolerability of MDMA-assisted therapy for patients with treatment-resistant post-traumatic stress disorder (PTSD).

MAPS has received authorization by the US Food and Drug Administration (FDA) to establish an expanded access program for a limited patient population.

For the duration of the study, participants who remain in the program will be required to come off certain psychiatric medications. Participants will receive preparatory behavioral health therapy sessions before and integrative therapy sessions after each of 3 MDMA-assisted therapy sessions. The MDMA-assisted sessions, which will be conducted in an accredited medical setting, will last 6 to 8 hours.

The study is building on a Phase 3 trial by MAPS released in 2021 in which 88% of participants demonstrated a clinically significant reduction in PTSD symptoms 2 months after their last experimental session.

“We are grateful to be able to further investigate the potential therapeutic benefits MDMA may bring to people living with PTSD,” Paul Thambi, MD, co-founder of Sunstone Therapies and principal investigator of the study, said in a news release. “While the public often associates PTSD with military personnel, we know that many patients with cancer also have an emotional burden caused by trauma, some related to the diagnosis itself.

“We hope this trial sheds light on the treatment potential of psychedelic-assisted therapy, so in the future, any person affected by PTSD—including cancer patients—may have access to this therapy.”

Reference

Sunstone Therapies collaborates with MAPS to conduct clinical trial of MDMA-assisted therapy for PTSD. News release. Sunstone Therapies. September 14, 2022. Accessed September 16, 2022.