Shrinking the know–do gap in psychedelic-assisted therapy

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.