ISSN 0160-6689; 1555-2101;
2 papers in the library · publishing 2024-2025
J Clin Psychiatry September 1, 2025
Psychotherapeutic support is essential for safe and effective psychedelic-assisted therapy, and establishing consensus on its role is critical for the field's advancement.
J Clin Psychiatry August 21, 2024
The article examines the problem of functional unblinding in pivotal clinical trials of psychedelic medicines, where participants and clinicians can often guess treatment assignment due to the drugs' subjective effects, potentially biasing results. It argues that this unblinding threatens the integrity of placebo-controlled designs and discusses implications for the future of psychedelic research and regulation. The authors suggest that alternative trial designs, such as active comparators or novel blinding strategies, may be needed to produce credible evidence for regulatory approval.