Trials, trips, and tribulations: pathways for implementing psychedelic therapy in Ireland.
John R Kelly, Christopher Sheridan, Patricia Iusan, Lisa Coakley, Lisa Burke, Christine Brennan, Annie Macdonald, Jo-Hanna Ivers, Dominic Trepel, Garrath Tormey, Martha Finnegan, Gareth W Young, Andrew Harkin
The international journal of neuropsychopharmacology June 2, 2026 Peer reviewed DOI: 10.1093/ijnp/pyag028 via PubMed
Summary
Psilocybin and other classical psychedelics show potential for treating various mental health disorders, but recent larger-scale trials have reported more modest effects. While some countries have allowed regulated use of psychedelic therapies, the long-term impact on public health systems is still unclear. Ireland has a chance to learn from international experiences to plan for integrating these therapies into its healthcare system, addressing regulatory, implementation, and evaluation challenges.
Study at a glance
| Key finding | Recent phase 3 trials of psilocybin for treatment-resistant depression have shown more modest effects compared to earlier studies. |
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Abstract
Classical serotonergic psychedelics, such as psilocybin, show emerging evidence of therapeutic potential across a range of mental health disorders, including depression, anxiety, and substance use disorders, with indications of transdiagnostic efficacy. While early-phase studies yielded encouraging results, recent larger-scale phase 3 trials, such as those evaluating psilocybin for treatment-resistant depression, have shown more modest effects, and further findings from ongoing trials are awaited. Despite the absence of regulatory approvals from the U.S. Food and Drug Administration and European Medicines Agency, a small but growing number of countries have permitted psychedelic therapies within regulated clinical settings. Across these divergent international approaches, the long-term trajectory and real-world impact of these therapies within public health systems remain uncertain. In anticipation of potential future approval, Ireland has an opportunity to draw on international experience and proactively plan for the integration of psychedelic therapies. Building on emerging evidence, international frameworks, and Ireland-specific policy and health system features, this paper examines the challenges of integrating psychedelic therapies into the Irish public healthcare system. These challenges span regulatory approval, Health Technology Assessment, service implementation, workforce capacity, and the evaluation of long-term patient outcomes. The aim is to inform policymakers, practitioners, and researchers about key system-level considerations.