Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial
Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial
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DOI：
10.1111/add.12631
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发表时间：
2014-09-01
期刊：
影响因子：
6
通讯作者：
Arnsten, Julia H.
中科院分区：
文献类型：
--
作者：
Nahvi, Shadi;Ning, Yuming;Arnsten, Julia H.
目的 测试伐尼克兰辅助美沙酮维持吸烟者戒烟的有效性和安全性。设计多中心、随机、双盲、安慰剂对照试验，随机分配至 12 周的伐尼克兰 1 mg 每日两次 (n = 57) 或匹配安慰剂 (n = 55)，并进行现场咨询和电话咨询。在美国纽约州纽约市布朗克斯区制定城市美沙酮计划。参与者 美沙酮维持治疗患者，吸烟量 >= 5 支/天，有兴趣戒烟，美沙酮治疗稳定，目前没有 Axis I 精神障碍、自杀意念或近期自杀企图。测量 第 12 周时，通过过期一氧化碳 (CO) < 百万分之 8 验证的 7 天点戒断率（主要结果）；在第 2、4、8、12 或 24 周时经过一氧化碳 (CO) 验证的戒烟、每天吸烟、轴 I 精神疾病事件、自杀意念或严重不良事件 (SAE)（次要结果）。研究结果 各组之间的基线人口统计学、吸烟和临床因素相似。 24 周时的保留率为 90%。接受伐尼克兰治疗的受试者比接受安慰剂的受试者在第 12 周时更有可能实现戒烟（10.5% vs 0%，P = 0.03；效应大小 10.5%，95% 置信区间 (CI) = 4.4-19.3%）并减少吸烟（中位数为每天 5 支烟与 2 支烟，P < 0.001）。药物治疗停止后，这些作用不再维持。精神疾病事件（OR = 0.84，95% CI = 0.16, 4.4）和自杀[比值比（OR）= 0.88，95% CI 0.2, 3.9]在各组之间没有差异。没有出现精神或心脏 SAE。结论 伐尼克兰可以帮助美沙酮维持吸烟者短期戒烟。
Aims To test the efficacy and safety of varenicline as an aid to smoking cessation in methadone-maintained smokers. Design Multicenter, randomized, double-blind, placebo-controlled trial with random assignment to 12 weeks of varenicline 1 mg twice daily (n = 57) or matched placebo (n = 55), with in-person and telephone counseling. Setting Urban methadone programs in the Bronx, New York City, New York, USA. Participants Methadone maintenance patients, smoking >= 5 cigarettes/day, interested in quitting, stable in methadone treatment, without current Axis I psychiatric disorders, suicidal ideation or recent suicide attempts. Measurements Seven-day point prevalence abstinence verified by expired carbon monoxide (CO) < 8 parts per million at week 12 (primary outcome); carbon monoxide (CO)-verified abstinence, cigarettes/day, incident Axis I psychiatric illness, suicidal ideation or serious adverse events (SAEs) at weeks 2, 4, 8, 12 or 24 (secondary outcomes). Findings Baseline demographic, smoking and clinical factors were similar between groups. Retention at 24 weeks was 90%. Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0%, P = 0.03; effect size 10.5%, 95% confidence interval (CI) = 4.4-19.3%) and to reduce smoking (median five versus two cigarettes/day, P < 0.001) at 12 weeks. These effects were not maintained after drug treatment ceased. Incident psychiatric illness (OR = 0.84, 95% CI = 0.16, 4.4) and suicidality [odds ratio (OR) = 0.88, 95% CI 0.2, 3.9] were not different between groups. There were no psychiatric or cardiac SAEs. Conclusions Varenicline can aid short-term smoking abstinence in methadone-maintained smokers.