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Blinding Integrity in Psychedelic Randomized Clinical Trials: A Systematic Review.
Diana K Orsini1,2, Sabrina Wong1,2, Sara Di Luch1,2
1Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada.
JAMA Psychiatry
|April 15, 2026
Summary
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.
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.
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.
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