Thursday, September 15, 2022
Sunstone Therapies, a company dedicated to addressing the psychological effects of cancer, is pleased to announce the initiation of a new clinical trial focused on evaluating the safety and tolerability of MDMA-assisted therapy for individuals suffering from treatment-resistant post-traumatic stress disorder (PTSD). This trial is being sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research organization dedicated to the development of psychedelic medicine. MAPS has obtained authorization from the Food and Drug Administration (FDA) to establish an expanded access program specifically for a limited group of patients who meet the eligibility criteria outlined in the study.
Dr. Paul Thambi, co-founder of Sunstone Therapies and the principal investigator of the study, expressed gratitude for the opportunity to further explore the potential therapeutic benefits of MDMA in individuals living with PTSD. Dr. Thambi emphasized that while PTSD is commonly associated with military personnel, cancer patients also carry a significant emotional burden resulting from trauma, some of which is directly related to their diagnosis. The goal of this trial is to shed light on the treatment potential of psychedelic-assisted therapy, thereby ensuring that individuals affected by PTSD, including cancer patients, may have access to this innovative therapeutic approach in the future.
PTSD is a mental health condition triggered by highly distressing events, characterized by symptoms such as flashbacks, severe anxiety, intrusive thoughts, agitation, social withdrawal, insomnia, and emotional detachment. In the United States, over 8% of the population will experience PTSD at some point in their lives. Certain populations, including veterans of Iraq and Afghanistan, face an even higher risk, with more than 13% screening positive for PTSD in 2014. Additionally, approximately 1 in 5 individuals diagnosed with cancer will experience PTSD at least six months after their initial diagnosis. Unfortunately, more than 30% of individuals diagnosed with PTSD do not respond to FDA-approved treatments, such as antidepressants and selective serotonin reuptake inhibitors.
During the course of the study, enrolled participants who remain in the trial will gradually discontinue certain psychiatric medications under strict supervision. Each participant will receive preparatory behavioral therapy sessions prior to the MDMA-assisted therapy sessions, as well as integrative behavioral therapy sessions afterward. These therapy sessions will take place in a medically accredited setting, ensuring safety and comfort throughout the process. During each 6-to-8-hour MDMA-assisted therapy session, participants will be supported by licensed and extensively trained psychotherapists and monitored onsite by a team of therapists, medical doctors, and research personnel via live audio and video feeds. Data on the safety and tolerability of MDMA-assisted therapy for PTSD will be collected for up to one year to assess the impact of this therapy on participants' mental health.
The clinical trial will be conducted at The Bill Richards Center for Healing, a purpose-built facility dedicated to providing psychological and emotional support to cancer patients and caregivers. This center is situated within the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center in Rockville, MD. The trial is made possible through the generous funding of The Bob & Renee Parsons Foundation, along with individual donors, and is supported by MAPS. This study represents an important continuation of the MAPS Phase 3 trial, which was released in May 2021 and demonstrated a clinically significant reduction in PTSD symptoms in 88% of participants two months after the last experimental session.
Dr. Corine de Boer, Chief Medical Officer of MAPS Public Benefit Corporation, expressed excitement about collaborating with Sunstone Therapies on this clinical trial for treatment-resistant PTSD, a debilitating condition that existing treatments fail to adequately address in a substantial number of patients.