A REVIEW OF CLINICAL RESEARCH FOR A CLASS OF RAPIDLY-EMERGING BEHAVIORAL HEALTH INTERVENTIONS
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Studies at prestigious research institutions around the world are showing compelling results for psychedelics as treatments for serious mental health and substance use disorders when administered in clinical settings paired with therapeutic oversight. These psychedelic-assisted therapies are rapidly moving towards mainstream clinical applications. With unprecedented interest at hand, it is imperative to understand the clinical evidence that demonstrates the efficacy, effectiveness, and safety of this class of interventions. Psychedelic Medicine: A Review of Clinical Research for a Class of Rapidly-Emerging Behavioral Health Interventions is a review of seven psychedelic compounds, including a brief history, tolerability and safety considerations, a summary of clinical evidence by conditions, and recommendations for future adoption and/or research.
Across more than 200 relevant peer-reviewed studies covered in this report, the aggregate evidence is positive. While each compound has different, specific applications, the clinical evidence for PAT is showing noteworthy levels of effectiveness. In fact, compared to treatment as usual, such as psychopharmacology and talk therapy, a growing number of studies of these compounds demonstrate higher levels of short- and long-term effectiveness.
Research involving the medicinal use of psychedelics is showing significant promise. Several noteworthy highlights from recent studies include:
The world’s first FDA Phase 3 trial using MDMA to treat PTSD found that after three MDMA-assisted therapy sessions, 67 percent of participants no longer qualified for a PTSD diagnosis, and 88 percent experienced a clinically significant reduction in symptoms (Mitchell et al., 2021).
A Phase 2 trial found psilocybin was efficacious in treating major depressive disorder, with a clinically significant response in 71 percent of participants and remission from depression in 54 percent at four weeks post treatment (Davis et al., 2021).
Ketamine indicated effectiveness for treatment-resistant depression, with response rates over 60 percent within 24 hours, and lasting up to four weeks after end of treatment for a portion of patients (Wan et al., 2015).
Given the evidence outlined in our report for psychedelic-assisted therapy, limitations of treatment as usual for many mental health and substance use disorders, and the growing need for effective interventions, BrainFutures makes the following recommendations:
Certain PAT interventions with sufficient evidence levels for safety and efficacy should be rapidly adopted once approved by the FDA. BrainFutures believes a core segment of the rapidly evolving PAT field shows promising efficacy and safety, and should be made available as treatments as soon as regulatorily-required studies prove continued safety and efficacy outcomes. Specifically, BrainFutures recommends fast and widespread adoption for PAT therapies, including psilocybin- and MDMA-assisted therapies, upon FDA approval. In the short term, BrainFutures also recommends that the DEA release safeguards ensuring that the immunity protections of state and federal Right to Try Acts extend to investigational Schedule I substances for those with qualifying life-threatening illnesses.
Reimbursable and equitable access to approved psychedelic therapies is essential and all payers should adequately cover PAT treatments. Payers should cover all aspects of PAT for ketamine-assisted therapy and, eventually, MDMA- and psilocybin-assisted therapies, including assessment, therapeutic preparation, medication/dosing session (including compound, therapy, and observation), and integration therapy.
Public research dollars should be invested in advancing the field. Since the Schedule 1 classification of psychedelic compounds in 1970, the advancement of therapeutic clinical research has been largely dependent on private philanthropy. Given the demonstrated outcomes to date, public monies in this field are a much-needed investment to stem the tide of today’s mental health crisis.
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BrainFutures’ work in the field of psychedelic medicine is generously supported by:
Austin and Gabriela Hearst Foundation
Cammack Family Charitable Gift Fund
Darla Moore Foundation
Dick and Alex Simon
Steven & Alexandra Cohen Foundation
Walker Family Foundation
Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., … & Griffiths, R. R. (2021). Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder. JAMA Psychiatry, 78(5), 481-489. https://doi.org/10.1001/jamapsychiatry.2020.3285
Mitchell, J., Bogenschutz, M., Lilienstein, A., Harrison, C., Kleiman, S., Parker-Guilbert, K., . . . Doblin, R. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine, 1025-1033. https://doi.org/10.1038/s41591-021-01336-3
Wan, L.-B., Levitch, C. F., Perez, A. M., Brallier, J. W., Iosifescu, D. V., Chang, L. C., . . . Murrough, J. W. (2015). Ketamine safety and tolerability in clinical trials for treatment-resistant depression. Journal of Clinical Psychiatry, 247-52. https://doi.org/10.4088/jcp.13m08852