Moving psychedelic-assisted therapies from promising research into routine clinical practice: Lessons from the field of implementation science

Transl Behav Med. 2024 Nov 25;14(12):744-752. doi: 10.1093/tbm/ibae053.

Abstract

Psychedelics (e.g., 3,4-Methylenedioxymethamphetamine [MDMA], lysergic acid diethylamide [LSD], psilocybin) are molecules that have the potential to produce rapid therapeutic effects when paired with psychotherapy. Randomized clinical trials of psychedelic-assisted psychotherapy (PAT) have shown promising results for post-traumatic stress disorder (PTSD), depression, and substance use disorders. The U.S. Food and Drug Administration has acknowledged the promise of PAT, signaling potential approval of psilocybin-assisted therapy for depression by 2026. Given this timeline, implementation scientists must engage with PAT researchers, policymakers, and practitioners to think critically about bringing these promising new treatments into routine practice settings while maintaining quality and safety. This commentary aims to initiate a dialogue between implementation scientists and PAT researchers and practitioners on addressing these questions with a lens toward equity. Specifically, we discuss how the field of implementation science can support PAT stakeholders to accelerate the translational process from research into practice, focusing specifically on safety-net settings (i.e., Federally Qualified Health Centers and Veterans Affairs health systems) that serve historically marginalized populations. We use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework to illustrate five critical areas where implementation science can help move PAT from research into real-world practice. For each RE-AIM dimension, we highlight ways the field of implementation science can contribute tools (e.g., implementation strategies), methodologies (e.g., pragmatic hybrid implementation-effectiveness trials), and approaches (community-based participatory research) for establishing the safety, effectiveness, and accessibility of PAT for historically underserved communities.

Keywords: equity; implementation science; mental health; psilocybin; psychedelic-assisted therapy; safety-net health settings.

Plain language summary

Clinical trials of psychedelic-assisted therapy (PAT) have shown promising safety and efficacy results for treating a number of mental health conditions, including post-traumatic stress disorder, depression, anxiety/depression associated with life-threatening illnesses (e.g. cancer), eating disorders, and alcohol and tobacco use disorders. PAT researchers and practitioners must think critically about how to best bring these promising treatments into routine practice settings that are outside the confines of randomized clinical trials. This commentary aims to initiate an ongoing dialogue on how the field of implementation science can contribute tools, methodologies, and approaches to help move PAT from research into practice for historically underserved communities. We use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to illustrate five critical areas where PAT can help move from randomized control trials into practice. Throughout all the considerations we pose, we highlight how an equity lens is necessary to acknowledge and address harms caused to historically marginalized communities by policies like the “War on Drugs” and advocate that those most in need of PAT receive it first at safety-net health settings like Federally Qualified Health Centers and the Veterans Affairs.

MeSH terms

  • Depression / drug therapy
  • Hallucinogens* / administration & dosage
  • Hallucinogens* / therapeutic use
  • Humans
  • Implementation Science*
  • Psilocybin / administration & dosage
  • Psilocybin / therapeutic use
  • Psychotherapy* / methods
  • Stress Disorders, Post-Traumatic / drug therapy
  • Stress Disorders, Post-Traumatic / therapy
  • Substance-Related Disorders / therapy
  • United States

Substances

  • Hallucinogens
  • Psilocybin