Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects

Drummond E-Wen McCulloch; Matthias E. Liechti; Kim P.C. Kuypers; David Nutt; Johan Lundberg; Dea Siggaard Stenbæk; Guy M. Goodwin; Gerhard Gründer; Florence Butlen-Ducuing; Marion Haberkamp; Steffen Thirstrup; Gitte M. Knudsen

doi:10.1016/j.nsa.2024.103938

Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects

Drummond E-Wen McCulloch, Matthias E. Liechti, Kim P.C. Kuypers, David Nutt, Johan Lundberg, Dea Siggaard Stenbæk, Guy M. Goodwin, Gerhard Gründer, Florence Butlen-Ducuing, Marion Haberkamp, Steffen Thirstrup, Gitte M. Knudsen^*

^*Corresponding author for this work

Research output: Contribution to journal › (Systematic) Review article › peer-review

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.

Original language	English
Article number	103938
Number of pages	7
Journal	Neuroscience Applied
Volume	3
DOIs	https://doi.org/10.1016/j.nsa.2024.103938
Publication status	Published - 19 Feb 2024

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E-Wen McCulloch, D., Liechti, M. E., Kuypers, K. P. C., Nutt, D., Lundberg, J., Stenbæk, D. S., Goodwin, G. M., Gründer, G., Butlen-Ducuing, F., Haberkamp, M., Thirstrup, S., & Knudsen, G. M. (2024). Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects. Neuroscience Applied, 3, Article 103938. https://doi.org/10.1016/j.nsa.2024.103938

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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.",

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T2 - Clinical studies and regulatory aspects

AU - E-Wen McCulloch, Drummond

AU - Liechti, Matthias E.

AU - Kuypers, Kim P.C.

AU - Nutt, David

AU - Lundberg, Johan

AU - Stenbæk, Dea Siggaard

AU - Goodwin, Guy M.

AU - Gründer, Gerhard

AU - Butlen-Ducuing, Florence

AU - Haberkamp, Marion

AU - Thirstrup, Steffen

AU - Knudsen, Gitte M.

PY - 2024/2/19

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N2 - 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.

AB - 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.

U2 - 10.1016/j.nsa.2024.103938

DO - 10.1016/j.nsa.2024.103938

M3 - (Systematic) Review article

SN - 2772-4085

VL - 3

JO - Neuroscience Applied

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ER -

Knowledge gaps in psychedelic medicalisation: Clinical studies and regulatory aspects

Abstract

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