Shrinking the know-do gap in psychedelic-assisted therapy.

Psychedelic-assisted therapy (PAT) combines medication with psychotherapy, but many questions remain about how it works, for whom, and in what context. To avoid the typical 17-year delay between research and clinical practice, implementation science can help by simultaneously studying safety, effectiveness, and real-world delivery. Methods like sequential multiple assignment randomized trials (SMART), hybrid study designs, and fidelity measurement can speed implementation while maintaining quality and safety. Substantial changes to regulations, training, and access are needed to accommodate this multimodal therapy outside research settings. The authors advocate proceeding with accelerated caution.

Study at a glance

Abstract

There is a push to shrink the anticipated 17-year research-to-practice gap for psychedelic-assisted therapy (PAT), offering precarious hope to those with disabling mental health conditions. However, numerous questions regarding how PAT works, how well it works, for whom and in what context remain. Substantial changes to current systems of care, including regulatory approvals, clinical training and access will all be required to accommodate PAT, a multimodal therapy that combines pharmacological and psychotherapy components that are not routinely available outside clinical research settings. Implementation science can help to reduce the gap in a way that maintains scientific rigour by simultaneously examining the safety, effectiveness and implementation of PAT. Specifically, precision implementation science methods (for example, sequential multiple assignment randomized trial (SMART) designs), hybrid study designs, valid measurement of fidelity and use of theory-based models and frameworks for treatment development will accelerate the process of implementation while balancing safety and quality. The time to proceed, with accelerated caution, is now.