A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults
A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults
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DOI：
10.1016/j.drugalcdep.2017.04.020
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发表时间：
2017-08-01
影响因子：
4.2
通讯作者：
Levin, Frances R.
中科院分区：
文献类型：
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作者：
Gray, Kevin M.;Sonne, Susan C.;Levin, Frances R.
背景：大麻使用障碍（CUD）是一种普遍存在的损害性疾病，现有的心理社会治疗方法效果有限。鉴于最近的研究结果支持 N-乙酰半胱氨酸 (NAC) 对青少年 CUD 的疗效，本试验的目的是评估其对成人的疗效。 方法：在一项为期 12 周的双盲随机安慰剂对照试验中，年龄 18-50 岁的 CUD 寻求治疗的成年人 (N = 302) 入组了六个国家药物滥用治疗临床试验网络附属临床试验 以 1:1 的比例随机接受 NAC 1200 mg (n = 153) 或安慰剂 (n = 149) 的 12 周疗程，每天两次。所有参与者都接受了应急管理（CM）和医疗管理。主要疗效指标是治疗期间 NAC 组和安慰剂组参与者的尿液大麻素检测呈阴性的几率。 结果：没有统计学显着证据表明 NAC 组和安慰剂组在大麻戒断方面存在差异（比值比 = 1.00，95% 置信区间 0.63-1.59，p = 0.984）。总体而言，NAC 组中 22.3% 的尿液大麻素检测呈阴性，而安慰剂组中这一比例为 22.4%。许多参与者不遵守药物治疗；药物依从亚组内的探索性分析显示，治疗组的戒断结果没有显着差异。结论：与之前在青少年中的研究结果相反，没有证据表明，与安慰剂加 CM 相比，NAC 1200 mg 每日两次加 CM 对成人 CUD 的疗效存在差异。患有 CUD 的青少年和成人之间的这一差异可能受到发育差异、大麻使用情况、对嵌入式行为治疗的反应、药物依从性和其他因素的影响。
Background: Cannabis use disorder (CUD) is a prevalent and impairing condition, and established psychosocial treatments convey limited efficacy. In light of recent findings supporting the efficacy of N-acetylcysteine (NAC) for CUD in adolescents, the objective of this trial was to evaluate its efficacy in adults.Methods: In a 12-week double-blind randomized placebo-controlled trial, treatment-seeking adults ages 18-50 with CUD (N = 302), enrolled across six National Drug Abuse Treatment Clinical Trials Network-affiliated clinical sites, were randomized in a 1:1 ratio to a 12-week course of NAC 1200 mg (n = 153) or placebo (n = 149) twice daily. All participants received contingency management (CM) and medical management. The primary efficacy measure was the odds of negative urine cannabinoid tests during treatment, compared between NAC and placebo participants.Results: There was not statistically significant evidence that the NAC and placebo groups differed in cannabis abstinence (odds ratio = 1.00, 95% confidence interval 0.63-1.59, p = 0.984). Overall, 22.3% of urine cannabinoid tests in the NAC group were negative, compared with 22.4% in the placebo group. Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group.Conclusions: In contrast with prior findings in adolescents, there is no evidence that NAC 1200 mg twice daily plus CM is differentially efficacious for CUD in adults when compared to placebo plus CM. This discrepant finding between adolescents and adults with CUD may have been influenced by differences in development, cannabis use profiles, responses to embedded behavioral treatment, medication adherence, and other factors.