Psychedelic-assisted therapy as a complex intervention: implications for clinical trial design

S. D. Muthumaraswamy et al., including Eduardo Schenberg; Therapeutic Advances in Psychopharmacology

Co-authored by Petrie-Flom Center’s Psychedelic Use, Law, and Spiritual Experience (PULSE) Affiliated Researcher, Eduardo Schenberg. Psychedelic-assisted therapy (PAT) has typically been evaluated using conventional randomised controlled trials (RCTs), which assess treatment efficacy under highly controlled conditions. However, PAT constitutes a complex intervention, integrating pharmacological, psychotherapeutic and contextual elements that interact dynamically with patient experiences and healthcare settings.