Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling.

Autor: Henningfield JE; PinneyAssociates, Inc, 4800 Montgomery Lane, Suite 400, Bethesda, MD, USA; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: jhenning@pinneyassociates.com., Coe MA; PinneyAssociates, Inc, 4800 Montgomery Lane, Suite 400, Bethesda, MD, USA., Griffiths RR; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Belouin SJ; Substance Abuse and Mental Health Services Administration, Rockville, MD, USA., Berger A; Chief of Pain and Palliative Care, Senior Research Clinician (Full Professor). National Institutes of Health Clinical Center, Bethesda, MD, USA., Coker AR; MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA; Department of Neurology, University of California, San Francisco, CA, USA., Comer SD; Columbia University, Irving Medical Center, New York State Psychiatric Institute, New York, NY, USA., Heal DJ; DevelRx Ltd. BioCity, Nottingham, And Department of Pharmacy and Pharmacology University of Bath, Bath, UK., Hendricks PS; Department of Health Behavior, School of Public Health, University of Alabama at Birmingham, USA., Nichols CD; Department of Pharmacology and Experimental Therapeutics, Louisiana State University Health Sciences Center, USA., Sapienza F; Partner, The Drug and Chemical Advisory Group, LLC, Fairfax, VA, USA., Vocci FJ; Friends Research Institute, Baltimore, MD, USA., Zia FZ; Department of Health & Human Services National Institutes of Health, National Cancer Institute Division of Cancer Treatment & Diagnosis, Washington, DC, USA.
Jazyk: angličtina
Zdroj: Neuropharmacology [Neuropharmacology] 2022 Nov 01; Vol. 218, pp. 109220. Date of Electronic Publication: 2022 Aug 17.
DOI: 10.1016/j.neuropharm.2022.109220
Abstrakt: New medicines containing classic hallucinogenic and entactogenic psychedelic substance are under development for various psychiatric and neurological disorders. Many of these, including psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are Schedule I controlled substances of the United States Controlled Substances Act (US CSA), and similarly controlled globally. The implications of the CSA for research and medicines development, the path to approval of medicines, and their subsequent removal from Schedule I in the US are discussed. This entire process occurs within the framework of the CSA in the US and its counterparts internationally in accordance with international drug control treaties. Abuse potential related research in the US informs the eight factors of the CSA which provide the basis for rescheduling actions that must occur upon approval of a drug that contains a Schedule I substance. Abuse-related research also informs drug product labeling and the risk evaluation and mitigation strategies (REMS) will likely be required for approved medicines. Human abuse potential studies typically employed in CNS drug development may be problematic for substances with strong hallucinogenic effects such as psilocybin, and alternative strategies are discussed. Implications for research, medicinal development, and controlled substance scheduling are presented in the context of the US CSA and FDA requirements with implications for global regulation. We also discuss how abuse-related research can contribute to understanding mechanisms of action and therapeutic effects as well as the totality of the effects of the drugs on the brain, behavior, mood, and the constructs of spirituality and consciousness.
(Copyright © 2022. Published by Elsevier Ltd.)
Databáze: MEDLINE
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