The clinical trial will be testing the safety and tolerability of MDMA-assisted therapy for patients living with treatment-resistant post-traumatic stress disorder (PTSD).
Sunstone Therapies, a company dedicated to treating the psychological effects of cancer, will be carrying out the trial which is sponsored by the Multidisciplinary Association for Psychedelics Studies (MAPS), a non-profit research organisation that develops psychedelic medicine.
MAPS has received Food and Drug Administration authorisation to establish an expanded access programme for a limited group of patients who meet the study’s eligibility criteria.
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 US, more than 8 per cent of people will experience PTSD in their lifetime. Certain populations are at an even higher risk of living with PTSD — more than 13 per cent 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 per cent do not respond to FDA-approved treatments, such as antidepressants and selective serotonin reuptake inhibitors, demonstrating a need for new treatments.
Dr Paul Thambi, co-founder of Sunstone Therapies and principal investigator of the study, stated: “We are grateful to be able to further investigate the potential therapeutic benefits MDMA may bring to people living with PTSD.
“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.”
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 behavioural therapy sessions before and integrative behavioural 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 six to eight 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 centre 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 being funded through The Bob & Renee Parsons Foundation in concert with individual donors, as well as the support from MAPS.
This study will build upon the MAPS Phase 3 trial, released in May 2021, in which 88 per cent of participants demonstrated a clinically significant reduction in PTSD symptoms two months after the last experimental session.
MAPS Public Benefit Corporation’s Chief Medical Officer, Corine de Boer, MD, PhD, commented: “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.”
