Beyond the Hype: Pragmatic Solutions for Advancing Psychedelic Therapeutics
Psychiatric News April 19, 2024 Adrian Preda
Psychedelic clinical trials face unique methodological challenges in randomization, blinding, and control that require more stringent standards than typical psychotropic trials. Randomization is compromised when participants self-select based on interest in psychedelic experiences rather than clinical need; solutions include recruiting from clinical populations with documented diagnoses and excluding those with prior psychedelic use. Blinding is difficult because psychedelics produce noticeable physiological and psychological changes; active controls with similar effects but without therapeutic benefits, such as microdosing or subtherapeutic doses of other psychotropics, are recommended. Control is complicated by combining psychedelics with psychotherapy in nonclinical settings; a factorial design with additional arms for active control plus psychotherapy and active intervention plus placebo psychotherapy is proposed.