The therapeutic potential of psychedelics: the European regulatory perspective

• Published in: The Lancet (British edition) 2023-03, Vol.401 (10378), p.714-716
• Main Authors: Butlen-Ducuing, Florence, McCulloch, Drummond E-Wen, Haberkamp, Marion, Mattila, Taina, Bałkowiec-Iskra, Ewa, Aislaitner, Georgios, Balabanov, Pavel, Lundberg, Johan, Stenbæk, Dea Siggaard, Elferink, Andre, Knudsen, Gitte M, Thirstrup, Steffen
• Format: Article
• Language: English
• Subjects: Access control; Addictions; Blood pressure; Clinical trials; Councils; Drug dosages; Drug metabolism; End of life; Hallucinogens - therapeutic use; Humans; LSD; Lysergic acid diethylamide; Lysergide; Medicin och hälsovetenskap; Mental depression; Mental disorders; Mental health; Mescaline; Nervous system; Optimization; Pharmacokinetics; Pharmacology; Pharmacovigilance; Post traumatic stress disorder; Psilocybin; Psychedelic drugs; Psychiatrists; Psychological stress; Psychotherapy; Research methodology; Risk management; Visual effects
• ISSN: 0140-6736; 1474-547X; 1474-547X
• DOI: 10.1016/S0140-6736(23)00264-7

In the past decade there has been a renewed interest worldwide in psychedelics as potential treatments for various mental health conditions,3 such as treatment-resistant depression, addictive disorders, post-traumatic stress disorder, and end-of-life psychological distress.4–7 These psychoactive compounds have overlapping effects via different mechanisms of actions which, in the context of therapeutic use, remain to be established.8 Psychedelic substances induce alterations of consciousness, including visual effects, transient feelings of oneness with the universe, transcendence of time and space, and ego dissolution, but can also induce anxiety and psychological distress,9 which can be alleviated through interpersonal support during administration.10,11 Classic psychedelics act via 5-HT2A receptor agonism and include mescaline, N,N-dimethyltryptamine, lysergic acid diethylamide, and psilocybin. [...]investigation of potential effects is warranted, including anxiety with derealisation, headaches, increased blood pressure, tachycardia, and suicidal ideations and behaviours.20,21 Safety data on drug–drug interactions are also important, especially for regular co-administration with other medications.22 Possible separation of acute versus long-term effects should be further elucidated: can the acute psychedelic effects be separated from the long-term effects? Regulatory tools can be used to achieve this (eg, summary of product characteristics, risk management plan, and pharmacovigilance studies) together with additional risk minimisation measures, such as educational materials, appropriate training of staff, and controlled access programmes, which have been successfully implemented in the EU since 2019 after the authorisation of esketamine for treatment-resistant major depression in adults.23 Additionally, the UN classification of psychedelic substances as schedule 1 drugs24 might need to be revised given the emerging research on psychedelics.