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

Oct 17, 2024Translational behavioral medicine

Bringing psychedelic-assisted therapies from research into regular medical use: Insights from implementation science

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Abstract

The U.S. Food and Drug Administration may approve psilocybin-assisted therapy for depression by 2026.

Psychedelic-assisted psychotherapy has shown potential for rapid therapeutic effects in conditions like PTSD, depression, and substance use disorders.
Implementation scientists are encouraged to collaborate with PAT researchers and practitioners to ensure the safe integration of these therapies into routine practice.
The commentary emphasizes the importance of equity in bringing psychedelic-assisted therapy to historically marginalized populations.
The RE-AIM Framework is proposed as a tool to address five critical areas for effective translation of research into practice regarding PAT.
Methods such as community-based participatory research and pragmatic hybrid implementation-effectiveness trials are suggested to enhance safety and accessibility of PAT.

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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.

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

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