Evidence map›Paper›PMID 41645048›Full record

ArticleJournal of psychopharmacology (Oxford, England)2026

Challenges with clinical trial participants in studies with classical psychedelics: A position statement from the National Network of Depression Centers' task group on psychedelics and related compounds.

Benjamin R Lewis, Matthew J Reid, Andrew M Novick, Kevin Byrne, Mark J Niciu, Gregory A Fonzo, Thomas D Meyer, David Feifel, Rif S El-Mallakh, Jair Soares and 2 more

Abstract readConsensus Statement
In one paragraph

Article in Journal of psychopharmacology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Benjamin R LewisDepartment of Psychiatry, University of Utah Huntsman Mental Health Institute, Salt Lake City, USA.ORCID 0000-0003-0118-1053
Matthew J ReidDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Andrew M NovickDepartment of Psychiatry, University of Colorado, Denver, USA.
Kevin ByrneDepartment of Psychiatry, University of Utah Huntsman Mental Health Institute, Salt Lake City, USA.
Mark J NiciuDepartment of Psychiatry, Roy J. and Lucille A Carver College of Medicine, University of Iowa, USA.
Gregory A FonzoCharmaine and Gordon McGill Center for Psychedelic Research and Therapy, University of Texas at Austin, USA.
Thomas D MeyerDepartment of Psychiatry and Behavioral Sciences, University of Texas at Houston, USA.
David FeifelKadima Neuropsychiatric Institute, La Jolla, CA, USA.
Rif S El-MallakhDepartment of Psychiatry and Behavioral Sciences, University of Louisville, KY, USA.
Jair SoaresDepartment of Psychiatry and Behavioral Sciences, University of Texas at Houston, USA.
Trisha SuppesDepartment of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.
Frederick S BarrettDepartment of Psychiatry and Behavioral Sciences, Center for Psychedelic and Consciousness Research, Johns Hopkins School of Medicine, Baltimore, MD, USA.

Funding

Neurobiology of hormonal contraceptionK23HD110435 · NICHD · UNIVERSITY OF COLORADO DENVER · PI Andrew Michael Novick · 2023 to 2026
$643k
NICHD NIH HHS K23 HD110435
6 · The paper itself

Abstract

rationaleClassical psychedelics-a broad class of compounds that include psilocybin, lysergic acid diethylamide, dimethyltryptamine, and mescaline-have shown significant promise for the treatment of mental health conditions in recent clinical trials. Organizations such as the National Network of Depression Centers (NNDCs) can play a pivotal role in uniting researchers and clinicians working in this field to explore and synthesize existing evidence as well as characterize emerging challenges.

objectivesWe outline several categories of challenges that have emerged in the context of clinical trials with psychedelic drugs, drawing from our collective empirical observations as well as the extant literature. While these challenges have been presented in the context of clinical trial environments, many of them are likely to persist if and when psychedelic treatments become approved and are implemented in psychiatric clinical practice.

resultsWe describe four categories of challenges in the context of clinical trial participants-(1) treatment nonresponse, (2) expectancy effects and functional unblinding, (3) post-session psychological difficulties, and (4) contagion effects-and provide management strategies for study teams to mitigate associated risks.

conclusionsClassical psychedelics show therapeutic promise as mental health treatments. Studying them properly presents unique and unprecedented challenges that require researchers to develop sophisticated strategies to navigate nonresponse, expectancy effects, functional unblinding, post-session psychological issues, and possible contagion effects to responsibly advance this field. The NNDC and similar organizations are well-positioned to guide best practices and ensure the responsible advancement of this promising field.

Indexed as

Clinical Trials as TopicHallucinogensHumansHallucinogensdepressionmood disorderspsilocybinpsychedelicstreatment resistance

Identifiers

PMID41645048
PMCPMC13615523

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.