Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, 67 President St., MSC 861, Charleston, SC, 29425, USA; Hollings Cancer Center, Medical University of South Carolina, 86 Jonathan Lucas St., Charleston, SC, 29425, USA.
East Tennessee State University, Center for Rural Health Research, Department of Biostatistics and Epidemiology, 104 Lamb Hall, Johnson City, TN, 37612, USA.
Drug Alcohol Depend. 2021 Aug 1;225:108815. doi: 10.1016/j.drugalcdep.2021.108815. Epub 2021 Jun 18.
There is robust preclinical literature and preliminary clinical findings supporting the use of N-Acetylcysteine (NAC) to treat substance use disorders, including tobacco use disorder (TUD). However, randomized controlled trials have yielded mixed results and NAC's efficacy for TUD has not been established. The goals of this study were to assess the efficacy of NAC in promoting early and end-of-treatment abstinence and preventing relapse among adult smokers.
This randomized, double-blinded clinical trial enrolled adult, daily smokers (N = 114; ages 23-64; 51 % female; 65 % White; 29 % Black/African American; 7% Hispanic/Latinx), who were randomized 1:1 to receive NAC (n = 59) or placebo (n = 55) (1200 mg b.i.d.) for eight weeks. Participants received brief cessation counseling and incentives for abstinence during the first three days of the quit attempt. Primary outcomes: (i) carbon monoxide (CO)-confirmed abstinence during the first three days of the quit attempt.
(ii) time to relapse; (iii) biologically confirmed abstinence at Week 8.
No differences were found between NAC and placebo groups on measures of early abstinence (3-day quit attempt; 11 % for NAC vs. 15 % for placebo; all p > 0.11), time to relapse (p = 0.19), and end-of-treatment abstinence (7% for NAC vs. 11 % for placebo; all p > 0.40].
Results indicate that NAC is a well-tolerated pharmacotherapy but is unlikely to be efficacious as a monotherapy for TUD in adults. Considered in the collective context of other research, NAC may potentially be more useful in a younger population, as a combination pharmacotherapy, or in the presence of more intensive psychosocial treatment.
有大量的临床前文献和初步的临床发现支持使用 N-乙酰半胱氨酸 (NAC) 来治疗物质使用障碍,包括烟草使用障碍 (TUD)。然而,随机对照试验的结果喜忧参半,NAC 治疗 TUD 的疗效尚未确定。本研究的目的是评估 NAC 在促进成年吸烟者早期和治疗结束时的戒烟以及预防复发方面的疗效。
这项随机、双盲临床试验纳入了成年、每日吸烟的成年人(N=114;年龄 23-64 岁;51%为女性;65%为白人;29%为黑人和非裔美国人;7%为西班牙裔/拉丁裔),他们被随机分为 1:1 接受 NAC(n=59)或安慰剂(n=55)(1200mg 每日两次)治疗八周。参与者在戒烟尝试的头三天接受了简短的戒烟咨询和戒烟奖励。主要结局:(i)戒烟尝试的头三天内通过一氧化碳(CO)确认的戒烟。
(ii)复发时间;(iii)第 8 周时通过生物标志物确认的戒烟。
NAC 和安慰剂组在早期戒烟(3 天戒烟尝试;NAC 组为 11%,安慰剂组为 15%;所有 p>0.11)、复发时间(p=0.19)和治疗结束时的戒烟率(NAC 组为 7%,安慰剂组为 11%;所有 p>0.40)方面均无差异。
结果表明,NAC 是一种耐受性良好的药物治疗方法,但作为成人 TUD 的单一疗法不太可能有效。考虑到其他研究的综合情况,NAC 可能在年轻人群中、作为联合药物治疗或在更强化的心理社会治疗中更有用。