Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials
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Abstract
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.
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There is a general call for more effective active placebo conditions and systematic reporting of blinding efficacy.
“leading to a general call for more effective active placebo conditions and a systematic reporting of blinding efficacy [32–34].”
Systematic unblinding has been raised as a major threat to the validity of extant findings from double-blind psychedelic-assisted therapy trials due to high expectancy, presumably resulting in large placebo and nocebo effects in the experimental and control groups, respectively.
“systematic unblinding has been raised as a major threat to the validity of extant findings from ‘double blind’ PAT trials due to high expectancy, presumably resulting in large placebo and nocebo effects in the experimental group and the control group, respectively [32–34].”
Blinding efficacy for participants and therapists and expectancy for participants will be assessed and reported.
“blinding efficacy (participants, therapists) and expectancy (participants) will be assessed and reported, as recommended in the literature [32–34].”
The study proposes an active placebo condition aimed at maintaining blinding, while systematically assessing and reporting blinding efficacy in participants and therapists.
“proposing an active placebo condition aimed at maintaining blinding, while systematically assessing and reporting blinding efficacy in participants and therapists.”
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- Authors
- Aday, J. S., Heifets, B. D., Pratscher, S. D., Bradley, E., Rosen, R., & Woolley, J. D.
- Affiliations
- San Francisco VA Medical Center (US)
- Stanford Medicine (US)
- University of Florida Health (US)
- Corresponding author
- Aday, Jacob S.
- Heifets, Boris D.
- Pratscher, Steven D.
- Bradley, Ellen
- Rosen, Raymond
- Woolley, Joshua D.
- Venue
- Psychopharmacology
- Published
- 2022-04-01
- Volume
- 239
- Issue
- 6
- Pages
- 1989-2010
- ISSN
- 0033-3158 (ISSN-L)
- 1432-2072
- PMC
- PMC10184717
- OpenAlex
- W4226207502
- Cited by
- 237
- References
- 174
- Citations by year
- 2026: 49 · 2025: 59 · 2024: 64 · 2023: 47 · 2022: 18
- FWCI
- 7.84
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- public-domain
- www.springer.com/tdm (tdm)
- www.springer.com/tdm (vor)
- Locations
- Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- PsyArXiv (OSF Preprints) (submittedVersion)
- PsyArXiv (OSF Preprints) (submittedVersion, public-domain)
- Funders
- U.S. Department of Veterans Affairs (IK4 CX002090)
- University of California, San Francisco
- National Institute on Aging (T32AG049673)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- placebo effect, nocebo effect, expectancy effects, active placebo, treatment expectations, bias mitigation, research design, participant recruitment
- MeSH terms
- Hallucinogens, Humans, Motivation, Psychotherapy, Research Design
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