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N-乙酰半胱氨酸辅助戒烟用于同时使用烟草和大麻的双重使用者:一项随机对照试验的方案和原理。

N-acetylcysteine for smoking cessation among dual users of tobacco and cannabis: Protocol and rationale for a randomized controlled trial.

机构信息

Mental Health Service (116B), San Francisco VA Health Care System, 4150 Clement St., San Francisco, CA 94121, USA; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, 401 Parnassus Ave., San Francisco, CA 94143, USA.

Mental Health Service (116B), San Francisco VA Health Care System, 4150 Clement St., San Francisco, CA 94121, USA; Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, 401 Parnassus Ave., San Francisco, CA 94143, USA.

出版信息

Contemp Clin Trials. 2023 Aug;131:107250. doi: 10.1016/j.cct.2023.107250. Epub 2023 Jun 2.

Abstract

BACKGROUND

Tobacco and cannabis co-use is a growing public health problem. The synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared environmental cues reinforcing use may make tobacco smoking cessation more difficult. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use. NAC's potential efficacy in treating addiction may be attributable to its central nervous system effects in reducing excessive glutamatergic activity, oxidative stress, and inflammation. To date, no RCT has examined NAC for smoking cessation among dual users of tobacco and cannabis.

METHOD

In a double-blind, placebo-controlled RCT, we will examine NAC for smoking cessation among dual users of tobacco and cannabis. Sixty adult cigarette-cannabis co-users are randomized to receive NAC 3600 mg per day or placebo over 8 weeks. Participants in both groups receive 8 weekly cognitive behavioral therapy sessions addressing smoking cessation and cannabis reduction. Outcomes are assessed at Weeks 0, 4, 8, and 12. Primary aims are to determine NAC's efficacy in decreasing cigarette craving, nicotine dependence, and use; and cannabis craving and use. Exploratory aims include examination of changes in neurocognition with NAC and their potential mediational effects on cigarette and cannabis use outcomes.

CONCLUSION

Results will inform smoking cessation treatment among dual users of tobacco and cannabis.

CLINICALTRIALS

gov Identifier: NCT04627922.

摘要

背景

烟草和大麻共同使用是一个日益严重的公共卫生问题。大麻和尼古丁对介导奖赏的神经生物学系统以及共享的环境线索产生的协同作用可能使戒烟变得更加困难。N-乙酰半胱氨酸(NAC)是一种获得美国食品和药物管理局批准的药物和非处方药,在减少烟草和大麻的渴望和使用方面,动物研究和随机对照试验(RCT)显示出了希望。NAC 治疗成瘾的潜在疗效可能归因于其在中枢神经系统中的作用,可减少谷氨酸能过度活动、氧化应激和炎症。迄今为止,尚无 RCT 研究 NAC 对同时使用烟草和大麻的戒烟者的疗效。

方法

在一项双盲、安慰剂对照 RCT 中,我们将研究 NAC 对同时使用烟草和大麻的戒烟者的疗效。将 60 名成年香烟-大麻共同使用者随机分为 NAC 组(每天 3600mg)或安慰剂组,疗程为 8 周。两组参与者均接受 8 周的认知行为疗法,以解决戒烟和减少大麻使用的问题。在第 0、4、8 和 12 周评估结果。主要目的是确定 NAC 降低吸烟渴望、尼古丁依赖和使用的疗效;以及大麻的渴望和使用。探索性目标包括检查 NAC 对神经认知的变化及其对吸烟和大麻使用结果的潜在中介作用。

结论

结果将为同时使用烟草和大麻的戒烟者提供戒烟治疗的信息。

临床试验

gov 标识符:NCT04627922。

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