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
Neurosci Appl January 11, 2024 DOI: 10.1016/j.nsa.2024.103938 via PubMed Central
Summary
AI-generated from the abstractPsychedelic drugs like psilocybin and LSD are being tested in clinical trials for psychiatric and neurological conditions, with phase 2 studies showing particular promise for depression. At a 2023 European College of Neuropsychopharmacology meeting, experts identified key knowledge gaps that need addressing for successful medical implementation. These include understanding how these drugs work in the body (pharmacokinetics and pharmacodynamics), comparing different psychedelics, exploring the link between the duration of subjective effects and therapeutic outcomes, studying polypharmacology, and assessing the role of psychological support. The article also presents perspectives from the European Medicines Agency and Health Technology Assessors on what is most needed for medical adoption in Europe.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Psychedelic treatment Psychedelic therapeutics Psychedelics for therapy Drug trials |
| Citations | 10 |
| Key finding | 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.