The Use of Placebo in Randomized Controlled Trials Involving Psychedelic Assisted Therapy: A Systematic Review of Challenges and Methodology

Abstract

Recent years have seen an upsurge in randomized controlled trials utilizing psychedelics as potential therapeutic agents in disorders including Post Traumatic Stress Disorder (PTSD), Substance Use Disorder (SUD), Generalized Anxiety Disorder (GAD), and Major Depressive Disorder (MDD). However, a notable methodological challenge is the complexity of blinding subjects undergoing psychedelic experiences. In order to better elucidate the therapeutic efficacy of psychedelic assisted therapies, placebo methodology must be investigated further. As such, the present systematic review examines Placebo Controlled randomized trials involving psychedelic assisted therapies to evaluate methodology and highlight challenges. We conducted a systematic review of PubMed, MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Psycinfo, Embase, and Web of Science Core Collection to examine: (1) Experimental Characteristics and Methodology, (2) Placebo Characteristics and Utilization, and (3) Safety and Tolerability.

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