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Blinding Integrity in Psychedelic Randomized Clinical Trials: A Systematic Review.

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Psychoactive effects of psychedelic drugs often lead to functional unblinding in clinical trials, compromising efficacy results. Standardized blinding assessments are crucial for accurate psychiatric disorder treatment research.

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Area of Science:

  • Psychiatry
  • Clinical Trials
  • Pharmacology

Background:

  • Psychedelic drugs have psychoactive effects that can compromise blinding in randomized clinical trials (RCTs).
  • Functional unblinding, where participants or raters identify treatment allocation by subjective effects, can bias outcomes through expectancy effects.
  • This bias challenges the validity of efficacy estimates and regulatory acceptance of psychedelic treatments.

Purpose of the Study:

  • To systematically quantify the prevalence of blinding integrity assessment in psychedelic RCTs.
  • To determine the extent of functional unblinding in psychedelic RCTs for psychiatric disorders.

Main Methods:

  • A systematic review adhering to PRISMA guidelines was conducted.
  • Searched OVID, MEDLINE, Embase, and APA PsycINFO (January 2020–December 2025), with manual searches for earlier studies.
  • Included RCTs of psychedelics as psychiatric interventions, extracting data on blinding integrity assessment methods and results.

Main Results:

  • Of 112 RCTs reviewed, only 29.5% assessed blinding integrity, yet 57.1% cited it as a limitation.
  • Functional unblinding was substantial across various psychedelics, with some trials reporting over 90% unblinding rates.
  • Ketamine trials rarely assessed blinding, but showed better preservation with midazolam compared to saline controls; no control strategy consistently achieved ideal blinding.

Conclusions:

  • Functional unblinding is pervasive in psychedelic RCTs, raising concerns about the validity of efficacy findings.
  • Few trials assess blinding or expectancy, indicating a need for standardized measures and innovative designs.
  • Future research must differentiate true pharmacological effects from expectancy-driven responses in psychedelic treatment studies.