In order to most effectively use psychedelic-assisted therapies to treat PTSD, it is vital to understand the neurobiological mechanisms behind these compounds and design the best clinical protocols for delivering them to patients. We are excited to lead research in these key areas.
Clinical Trials with Psychedelic Therapies
MDMA-assisted psychotherapy represents a revolutionary new modality of care for patients with PTSD. Although industry-sponsored Phase 2 and Phase 3 studies have demonstrated promising results, it is critical to obtain information about how this therapy might work in complex patients with multiple mental health issues.
One of our Center’s primary goals is to provide leadership in working with MDMA-assisted psychotherapy for PTSD so as to pave the way for the use of psychedelics once this approach is approved by the FDA. The Center also seeks to examine the mechanisms involved in resilience and recovery so that MDMA-assisted psychotherapy and related treatments can be scaled and delivered more effectively. To this end, the Center has proposed its first study to investigate whether a two-dose MDMA treatment regimen is as effective in reducing PTSD symptoms as a three-dose regimen.
The Center will also examine issues associated with cost and scaling of MDMA-assisted psychotherapy, as well as developing and tailoring the treatment to conform to practices in settings where there may be barriers, restrictions, or other concerns. These protocols will test the efficacy and cost efficiency of different models for delivering MDMA-assisted psychotherapy, including the number of sessions and group modalities. Through this work, the Center will also consider the patients and providers who are more likely to welcome participation in such treatments and identify barriers to participation, including misperceptions, fears, and contraindications.
In addition, the Center will conduct clinical trials using MDMA, psilocybin, and other psychedelic compounds with a focus on their use for implementation in traditional clinical settings.
Neurobiological Research of Psychedelic Compounds
Drawing on the extensive experience of Rachel Yehuda, PhD, as a leader in examining neurobiological mechanisms of psychotherapy and other treatments for PTSD, our Center will investigate the effects of psychedelics on brain function and molecular and cellular biology. This will be accomplished by obtaining brain images and blood samples before and after psychedelic administration in willing participants for the assessment of well-established biomarkers of PTSD and resilience.
Genome-wide epigenetic, gene expression, proteins, metabolites, immune markers, and hormones can be measured before and after treatment. The knowledge gained from these biomarkers will not only allow us to understand biological changes associated with recovery but will also help us understand how recovery with psychedelics may lead to more enduring, transformational changes. In addition, stem cell technology will be used to determine the impact of psychedelics on gene expression networks in neuronal cells reprogrammed from stem cells obtained from persons with and without PTSD.