Gray Kevin M, Sonne Susan C, McClure Erin A, Ghitza Udi E, Matthews Abigail G, McRae-Clark Aimee L, Carroll Kathleen M, Potter Jennifer S, Wiest Katharina, Mooney Larissa J, Hasson Albert, Walsh Sharon L, Lofwall Michelle R, Babalonis Shanna, Lindblad Robert W, Sparenborg Steven, Wahle Aimee, King Jacqueline S, Baker Nathaniel L, Tomko Rachel L, Haynes Louise F, Vandrey Ryan G, Levin Frances R
Medical University of South Carolina, Charleston, SC, United States.
National Institute on Drug Abuse Center for the Clinical Trials Network, Rockville, MD, United States.
Drug Alcohol Depend. 2017 Aug 1;177:249-257. doi: 10.1016/j.drugalcdep.2017.04.020. Epub 2017 Jun 10.
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.
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 1200mg (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.
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.
In contrast with prior findings in adolescents, there is no evidence that NAC 1200mg 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.
大麻使用障碍（CUD）是一种普遍存在且会造成损害的病症，已确立的心理社会治疗方法疗效有限。鉴于最近有研究结果支持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年人的疗效。
在一项为期12周的双盲随机安慰剂对照试验中，18至50岁寻求治疗的CUD成年人（N = 302），在六个国家药物滥用治疗临床试验网络附属临床地点入组，以1:1的比例随机分配接受为期12周的NAC 1200mg（n = 153）或安慰剂（n = 149）治疗，每日两次。所有参与者均接受应急管理（CM）和医疗管理。主要疗效指标是治疗期间尿大麻素检测呈阴性的几率，比较NAC组和安慰剂组参与者。
没有统计学上的显著证据表明NAC组和安慰剂组在大麻戒断方面存在差异（优势比 = 1.00，95%置信区间0.63 - 1.59，p = 0.984）。总体而言，NAC组22.3%的尿大麻素检测呈阴性，而安慰剂组为22.4%。许多参与者未坚持用药；在坚持用药的亚组内进行的探索性分析显示，各治疗组在戒断结果上没有显著差异。
与之前在青少年中的研究结果相反，没有证据表明每日两次服用1200mg NAC加CM与安慰剂加CM相比，对成年人的CUD有不同的疗效。青少年和成年CUD患者之间的这一差异可能受到发育、大麻使用情况、对嵌入式行为治疗的反应、用药依从性和其他因素的影响。
