AbstractDespite growing interest in psychedelic-assisted therapy (PAT) research, there remains a lack of consensus about key issues relevant to difficulties in predicting acute drug effects, and the role of therapeutic support in clinical trials. In the absence of a clear theoretical model to conceptualize multifaceted components in PAT research, dialogue across contexts (e.g., popular media, peer reviewed journals, conference settings) is becoming increasingly polarized and siloed. This has even contributed to somewhat unusual recommendations by the FDA and others that removing critical aspects of psychological and medical safety could enhance our ability to investigate the impact of these drugs on clinical outcomes. Considering the importance of determining and maximizing safety in ongoing PAT research, this commentary suggests that an ecological systems theory (EST) approach provides a structure to make contextual and practical factors a more explicit and testable component of research. Utilizing systems theory and Bronfenbrenner’s EST approach adapted for healthcare settings, we propose that a more detailed conceptual model in PAT research would enable more explicit consideration of contextual factors informing and influencing outcomes. This commentary is accompanied by a custom figure that illustrates application of this model for psychedelic research and highlights the limitations of current measurement of acute subjective experience.
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