Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.
Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
Am J Drug Alcohol Abuse. 2022 Sep 3;48(5):586-595. doi: 10.1080/00952990.2022.2114004. Epub 2022 Sep 12.
Problematic cocaine use remains a significant public health issue, particularly among women. However, no concerted efforts have been made to target a pharmacological treatment option for women with cocaine use disorder (CUD) despite preclinical, human laboratory, and a limited number of clinical studies demonstrating that progesterone can attenuate the effects of cocaine to a greater extent in women than men. To evaluate the safety, tolerability, and preliminary efficacy of progesterone for treating women with CUD. A 10-week double-blind randomized treatment trial was conducted. Prior to randomization, participants were required to achieve cocaine abstinence (1 week) before assignment to progesterone (up to 400 mg/day) or placebo. The primary efficacy outcomes were days to relapse and cocaine abstinence during the last 3 weeks of the trial. The frequency of side effects was also assessed. 227 women were assessed for eligibility. Twenty-five women entered treatment and 21 were randomized to progesterone (n = 11) or placebo (n = 10). The majority of women relapsed in less than 4 days with no differences between the two groups. Further, there were no significant differences between the progesterone and placebo groups in terms of cocaine abstinence during the last 3 weeks of the trial (27% and 10% respectively). The most commonly reported side effects were headache and fatigue, but no group differences were noted. Progesterone was well tolerated and safe and supports further study is in a larger sample to determine if exogenous progesterone is an effective treatment option for women with CUD.(ClinicalTrials.gov Identifier: NCT00632099).
可卡因问题仍然是一个重大的公共卫生问题，尤其是在女性中。然而，尽管有临床前、人体实验室和一些临床研究表明，孕激素在女性中比男性更能减轻可卡因的作用，但针对可卡因使用障碍（CUD）女性的药物治疗方案尚未得到一致关注。评估孕激素治疗女性可卡因使用者的安全性、耐受性和初步疗效。进行了一项为期 10 周的双盲随机治疗试验。在随机分组之前，要求参与者在分配给孕激素（高达 400mg/天）或安慰剂之前先达到可卡因戒断（1 周）。主要疗效结局是复发天数和试验最后 3 周的可卡因戒断。还评估了副作用的频率。对 227 名女性进行了资格评估。25 名女性接受了治疗，21 名女性被随机分配到孕激素组（n=11）或安慰剂组（n=10）。大多数女性在不到 4 天内复发，两组之间没有差异。此外，在试验的最后 3 周，孕激素组和安慰剂组在可卡因戒断方面没有显著差异（分别为 27%和 10%）。最常见的报告副作用是头痛和疲劳，但两组之间没有差异。孕激素耐受性良好且安全，并支持进一步在更大样本中研究，以确定外源性孕激素是否是 CUD 女性的有效治疗选择。（临床试验标识符：NCT00632099）。
