Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials

Autor:	Jacob S. Aday, Boris D. Heifets, Steven D. Pratscher, Ellen Bradley, Raymond Rosen, Joshua D. Woolley
Rok vydání:	2022
Předmět:	Psychiatry Pharmacology Motivation Placebo effect Treatment expectations Clinical Trials and Supportive Activities Psychology and Cognitive Sciences Evaluation of treatments and therapeutic interventions Recommendations Medical and Health Sciences Article Expectancies Psychotherapy Clinical trials Good Health and Well Being Masking Psychedelic therapy Clinical Research Research Design 6.1 Pharmaceuticals Complementary and Integrative Health Psychedelics Hallucinogens Humans
Zdroj:	Psychopharmacology (Berl) Psychopharmacology, vol 239, iss 6
ISSN:	1432-2072 0033-3158
DOI:	10.1007/s00213-022-06123-7
Popis:	RATIONALE: Psychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research. OBJECTIVE: In this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research. RESULTS: Although some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants’ expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies are discussed in the context of study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy. CONCLUSION: Incorporating the recommended design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increases the ability to discern treatment-specific effects of psychedelic therapy.
Databáze:	OpenAIRE
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