Blinding Integrity in Psychedelic Randomized Clinical Trials: A Systematic Review - PubMed
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- #Clinical Trials
- #Systematic Review
- #Psychedelics
- The systematic review aimed to assess the prevalence of blinding integrity evaluation and functional unblinding in psychedelic randomized clinical trials (RCTs) for psychiatric disorders.
- Functional unblinding refers to participants or raters correctly identifying treatment allocation based on the acute psychoactive effects of psychedelics, potentially biasing outcomes due to expectancy effects.
- Out of 112 RCTs reviewed, only 29.5% evaluated blinding integrity, while 57.1% cited blinding as a limitation.
- Substantial functional unblinding was found: psilocybin, LSD, and ayahuasca studies often reported blinding failure rates exceeding 90%, with MDMA trials also showing high rates.
- Ketamine trials rarely assessed blinding (17.9%) but showed better blinding preservation with midazolam controls compared to saline.
- No control strategy consistently ensured ideal blinding, highlighting concerns about the validity of efficacy findings and the need for improved methods.