Controlled Substance Staff, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20910, USA.
Psychopharmacology (Berl). 2019 Mar;236(3):845-860. doi: 10.1007/s00213-018-5129-8. Epub 2019 Apr 10.
Cathinones are amphetamine analogues that produce stimulant effects with rewarding properties. For many decades, synthetic cathinones have been used in the United States (USA) for abuse purposes, leading to concern about public safety by the federal government. Under the Controlled Substances Act (CSA), the federal government may place drugs with high abuse potential but no currently accepted medical use into Schedule I of the CSA. The process of scheduling an abusable drug involves both the Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), and the Department of Justice, through the Drug Enforcement Administration (DEA).
This paper details how numerous synthetic cathinones were placed under CSA control between 1973 and 2018, with an emphasis on 10 cathinones that were placed into Schedule I in 2017 (butylone, naphyrone, pentylone, pentedrone, 3-fluoro-N-methylcathinone (FMC), 4-FMC, 4-methyl-N-ethylcathinone, 4-methyl-pyrrolidinopropiophenone, alpha-pyrrolidinobutiophenone, and α-pyrrolidinopentiophenone). A summary is provided of the scientific and medical analysis performed by HHS, in the form of an Eight-Factor Analysis (8FA), as prescribed by the CSA. This 8FA was then evaluated and signed by the Assistant Secretary for Health at HHS and transmitted to DEA, which permanently placed the 10 cathinones into Schedule I after public notices were published into the Federal Register.
Understanding the scientific data, analysis, and complex process utilized by the US federal government in the CSA scheduling of cathinones with abuse potential and no accepted medical use is important for transparency in governmental decision-making.
苯丙胺类似物卡西酮具有兴奋和奖赏作用。几十年来，合成卡西酮在美国被用于滥用目的，引起了联邦政府对公共安全的关注。根据《管制物质法》（CSA），联邦政府可以将具有高度滥用潜力但目前无被认可医疗用途的药物列入 CSA 的附表 I。对一种滥用药物进行分类的过程涉及卫生与公众服务部（HHS），通过食品和药物管理局（FDA）和国家药物滥用研究所（NIDA），以及司法部，通过缉毒署（DEA）。
本文详细介绍了 1973 年至 2018 年期间有多少种合成卡西酮被纳入 CSA 管制，重点介绍了 2017 年被列入附表 I 的 10 种卡西酮（丁酮、去甲西泮酮、戊酮、戊基酮、3-氟-N-甲基卡西酮（FMC）、4-FMC、4-甲基-N-乙基卡西酮、4-甲基-吡咯烷丙基苯丙酮、α-吡咯烷丁基苯丙酮和 α-吡咯烷戊基苯丙酮）。本文提供了 HHS 通过 CSA 规定的八项因素分析（8FA）形式进行的科学和医学分析的摘要。HHS 的卫生助理部长对这 8FA 进行了评估和签署，并将其转交 DEA，DEA 在《联邦公报》上发布公告后，将这 10 种卡西酮永久列入附表 I。
了解美国联邦政府在具有滥用潜力且无被认可医疗用途的卡西酮的 CSA 分类中使用的科学数据、分析和复杂过程，对于政府决策的透明度很重要。
