致幻剂临床试验参与者体验与建议：PsyPAN 经验专家定性研究

ORIGINAL RESEARCH article

Front. Psychiatry

Sec. Psychopharmacology

Abstract

Background: While psychedelic treatments for difficult-to-treat mental health conditions are advancing, participant perspectives remain under-explored. This study examined former participants' experiences across recruitment, preparation, dosing, integration and study ending, and generated recommendations for future trials and treatment delivery. Methods: This qualitative descriptive study, informed by reflexive thematic analysis, included four Psychedelic Participant Advisory Network (PsyPAN) members who were former psychedelic-trial participants. They completed three remote focus groups on recruitment and screening, preparation and dosing, and post-dose integration and the post-study period. Three had joined treatment-resistant depression studies involving psilocybin or N,N-dimethyltryptamine; one had joined a psilocybin study for an eating disorder. A one-day workshop reviewed the analysis and developed recommendations, refined with wider PsyPAN input. Results: Five themes were developed. First, participants entered trials seeking potentially effective treatment but encountered procedures shaped by eligibility criteria, equipoise, randomisation, blinding, standardisation, fixed schedules and endpoint-driven evidence generation. Second, participants' accounts extended 'set and setting' to the clinical-trial context by showing how research-specific conditions, including treatment-allocation uncertainty, communication, staff conduct, time-limited support, study ending and the wider support matrix, shaped experience and could mitigate tensions between treatment-seeking and research requirements. Third, facilitators mediated between protocol requirements and participants' embodied, relational and psychological needs, particularly during dosing. Fourth, dosing was experienced as the beginning of an ongoing process of meaning-making, change and integration. Fifth, experiences after study ending varied; some participants described loss, grief or frustration, while all reported that further structured support would have been beneficial. They highlighted limited access to psychedelically informed care and advocated independent, trial-specific peer support. Recommendations emphasised clear communication, expectation management, distinction between research and treatment frames, reduced avoidable burden, staff continuity, participant agency, boundaries around touch and movement, involvement of support networks, and planning for integration and study ending. Conclusion: Relational, contextual and systemic factors shaped participants' experiences across recruitment, preparation, dosing, integration and study ending. Participant-informed practices should be considered when designing and delivering psychedelic studies, while recognising scientific, regulatory and resource constraints. Structured post-study peer support may address continuing support needs after trial completion.

Keywords

clinical trials, DMT, drug approval pathways, Participant perspectives, psilocybin, psychedelics

Received

09 August 2025

Accepted

24 August 2026

Copyright

© 2026 Seynaeve, Lilley, Lobo, Ermakova, Wells, Cleare and Rucker. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence:

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