ROCKVILLE, Md., Sept. 14, 2022 /PRNewswire/ -- Sunstone Therapies, a company dedicated to treating the psychological effects of cancer, announces today the launch of a new clinical trial to test the safety and tolerability of MDMA-assisted therapy for patients living with treatment-resistant post-traumatic stress disorder (PTSD). The trial is sponsored by the Multidisciplinary Association for Psychedelics Studies (MAPS), a non-profit research organization that develops psychedelic medicine. MAPS has received Food and Drug Administration authorization to establish an expanded access program for a limited group of patients who meet the study's eligibility criteria.
"We are grateful to be able to further investigate the potential therapeutic benefits MDMA may bring to people living with PTSD," said Dr. Paul Thambi, co-founder of Sunstone Therapies and principal investigator of the study. "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."
PTSD is a mental health condition caused by an extremely stressful event, with common symptoms, such as flashbacks, severe anxiety, uncontrollable thoughts, agitation, social isolation, insomnia, emotional detachment and more. In the U.S., more than 8% of people will experience PTSD in their lifetime. Certain populations are at an even higher risk of living with PTSD—more than 13% of Iraq and Afghanistan veterans screened positive for PTSD in 2014, and 1 in 5 people living with cancer will experience PTSD at least six months after their initial diagnosis. Of individuals diagnosed with PTSD, more than 30% do not respond to FDA-approved treatments, such as antidepressants and selective serotonin reuptake inhibitors.
For the duration of this study, enrolled participants who remain in the study will be required to safely come off certain psychiatric medications. Each participant will receive preparatory behavioral therapy sessions before and integrative behavioral therapy sessions after each of the three MDMA-assisted therapy sessions, all of which will transpire in an accredited medical setting, with a focus on safety and comfort. During each 6-to-8-hour MDMA-assisted therapy session, each participant will be supported by a licensed and extensively trained psychotherapist and monitored onsite by a combination of therapists, medical doctors and research personnel through live audio and video feeds. The staff will collect data on the safety and tolerability of MDMA-assisted therapy for PTSD for up to one year to evaluate the impact MDMA-assisted therapy may have on the participants' mental health.
The trial will take place at The Bill Richards Center for Healing, the first-of-its-kind purpose-built center providing psychological and emotional support for cancer patients and caregivers, located within the Adventist HealthCare Shady Grove Medical Center's Aquilino Cancer Center in Rockville, MD. The clinical trial is funded through the generosity of The Bob & Renee Parsons Foundation in concert with individual donors and supported by MAPS. This study will build upon the MAPS Phase 3 trial, released in May 2021, in which 88% of participants demonstrated a clinically significant reduction in PTSD symptoms two months after the last experimental session.
"We are excited for the opportunity to collaborate with Sunstone Therapies on this clinical trial in treatment-resistant PTSD, a serious, disabling condition for which existing treatments fall short in a significant number of patients," said Corine de Boer, MD, PhD, MAPS Public Benefit Corporation's Chief Medical Officer.
Sunstone Therapies is a company committed to accelerating and scaling the gold standard of psychedelic therapy in the medical setting by conducting clinical trials with drug manufacturers, providing tactical training for therapists in the field, and serving as the intermediary between cancer centers and psychedelic drug manufacturers. They are creating a network of cancer centers that offer psychedelic therapy for their patients suffering from depression, anxiety and other mental health conditions.