Blinding Integrity in Psychedelic Randomized Clinical Trials

What is the prevalence of blinding integrity assessment and the extent of functional unblinding in psychedelic randomized clinical trials (RCTs) for psychiatric disorders?Of 112 RCTs identified, 29.5% (n = 33) evaluated blinding integrity. Functional unblinding was substantial: psilocybin, lysergic acid diethylamide (LSD), and ayahuasca studies frequently reported blinding failure values of more than 90% among participants and raters; inert placebo-controlled 3,4-methylenedioxymethamphetamine (MDMA) trials exceeded 85%; ketamine trials rarely assessed blinding (17.9%) but showed improved preservation with midazolam vs saline controls.Functional unblinding is pervasive in psychedelic RCTs, underscoring the need for standardized assessment methods and improved trial designs to ensure valid efficacy evaluations.

Corresponding Author: Joshua D. Rosenblat MD, MSc, University Health Network, 399 Bathurst St, Main Pavilion 7-424, Toronto, ON M5T 2S8, Canada (joshua.rosenblat@uhn.ca).

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