Psilocybin and MDMA therapy are now in Phase 3 trials for Treatment Resistant Depression and Post Traumatic Stress Disorder, respectively. Meanwhile, other psychedelics are in earlier phases of development. Blinding is largely impossible in such trials, and psychological support is given as standard. A complex interplay between drug and non-drug effects is likely to mediate outcome.
Identifying this interplay may allow the optimization of the process of treatment by identifying key factors of "set" and "setting", informing models of therapy and how dosing session environments are set up. This could significantly impact how such treatments might be delivered, if they are approved for wider use. This collection focuses on non-drug factors that may serve as predictors and mediators of response to treatment with psychedelic therapy, including psilocybin, MDMA and related compounds. How might clinical trial designs be modified to capture salient factors beyond drug effects? Can open-science frameworks, "real world" trials and non-medical use of psychedelics be combined to interrogate "set" and "setting" in a way clinical trials cannot? If such research is fruitful, will it be clinically meaningful?
The article collection welcomes both data-driven, methodological and conceptual articles that explore these themes:
• Psilocybin
• MDMA
• Therapeutic response
• Predictors
• Mediators
Please submit your manuscript on our website, quoting the promo code FGVBW to indicate that your submission is for consideration in this Article Collection.
