Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects.
Drummond E-Wen Mcculloch, Matthias E. Liechti, Kim Pc Kuypers, David Nutt, Johan Lundberg, Dea Siggaard Stenbæk, Guy M. Goodwin, Gerhard Gründer, Florence Butlen-Ducuing, Marion Haberkamp, Steffen Thirstrup, Gitte M. Knudsen
Neuroscience Applied January 11, 2024 DOI: 10.1016/j.nsa.2024.103938 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Psychedelic treatment Psychedelic therapeutics Psychedelics for therapy Drug trials Medical studies Research studies Clinical trial data Optimal dosing Patient populations Knowledge gaps Inconsistencies Regulatory challenges Drug regulation Medical regulation Policy issues Varied regulatory frameworks Therapeutic application Medical adoption Treatment implementation Safe access Therapeutic potential Medical options |
| Citations | 10 |
| Key findings | Key knowledge gaps for medical implementation of psychedelic drugs include pharmacokinetic and pharmacodynamic characterisation, comparisons between psychedelics, the relation between subjective effects duration and outcomes, polypharmacology, and the impact of psychological support. |
Abstract
Psychedelic drugs including psilocybin and LSD are undergoing clinical trials for a range of psychiatric and neurological conditions, and have particularly shown substantial promise in phase 2 studies of depression. In this article we outline key knowledge gaps that may be imperative for a successful implementation of psychedelic drugs as medicines as identified by members of the European College of Neuropsychopharmacology at the New Frontiers Meeting in Nice (2023). Key themes include pharmacokinetic and pharmacodynamic characterisation, comparisons between psychedelics, the relation between the duration of subjective effects and therapeutic outcomes, polypharmacology, and the impact of psychological support. We conclude with a perspective from the European Medicines Agency and Heath Technology Assessors on the most pressing requirements for medical implementation in Europe.
Comparable studies
Other narrative reviews on psychedelic-assisted therapy, most cited first.
Citations in the library
Cited by 9
- A review of psychedelics trials completed in depression, informed by European regulatory perspectives. Neuroscience Applied 2025
- Temporal dynamics in neuroimaging as correlates of therapeutic response to psilocybin in major depressive disorder: A systematic review and critical appraisal Journal of Affective Disorders September 16, 2025
- Self-reported experiences and perspectives on using psychedelics to manage opioid use among participants of two Reddit communities. Addiction January 16, 2025
- Exploring the neurobiological correlates of psilocybin-assisted psychotherapy in eating disorders: a review of potential methodologies and implications for the psychedelic study design Journal of Eating Disorders December 27, 2024
- Bridging the reporting gap: Application of the ReSPCT guidelines in psilocybin clinical trial protocols. European Neuropsychopharmacology January 16, 2026
and 4 more in the library
Cites 56
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and 51 more in the library