This perspective (2022) argues that within the current regulatory framework (Controlled Substances Act (CSA) or similar worldwide), the use of psychedelics (also within research) is severely limited. However, using these guidelines (eight factors), the risk of psychedelics should not put them in Schedule I (most restrictive, no medical use). The authors thus argue for rescheduling, by building on the CSA’s own framework.
Abstract
“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.“
Authors: Jack E. Henningfield, Marion A. Coe, Roland R. Griffiths, Sean J. Belouin, Ann Berger, Allison R. Coker, Sandra D. Comer, David J. Heal, Peter S. Hendricks, Charles D. Nichols, Frank Sapienza, Frank J. Vocci & Farah Z. Zia
Summary of Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling
Introduction
Concerns about the abuse potential of psychedelic substances emerged in the 1960’s, and the US Drug Abuse Control Amendment (DACA) banned their sale and interstate commerce, likely contributing to reduced interest in pharmaceutical development.
Many types of substances can have hallucinogenic effects at high dosages, and this article focuses on classic indoleamine hallucinogenic psychedelics and phenethylamines which likely have higher abuse potential.
Psychedelic substances were placed in the highly restricted Schedule I of the 1970 US Controlled Substances Act, but US survey global monitoring showed that psychedelics and many other Schedule I substances, including cannabinoids, continued to be readily available and used for recreational and other purposes.
Find this paper
https://doi.org/10.1016/j.neuropharm.2022.109220
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