Clinical Trials Research Unit, School of Population Health, The University of Auckland, Auckland, New Zealand.
Addiction. 2011 Jun;106(6):1176-85. doi: 10.1111/j.1360-0443.2011.03419.x. Epub 2011 Apr 28.
To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months.
Single-blind, randomized controlled trial.
New Zealand.
A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use.
The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months.
No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR)=1.17, 95% confidence interval (CI): 1.02, 1.35, P=0.03], had a longer time to relapse (median 70 days versus 28 days, P<0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%).
In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. This trial is registered with the Australasian Clinical Trials Network Number: ACTRN 12606000451505.
确定为有戒烟意愿的吸烟者提供容易获得尼古丁替代疗法(NRT)、一段时间的熟悉和产品选择,对 6 个月时戒烟的影响。
单盲、随机对照试验。
新西兰。
共 1410 名拨打全国戒烟热线寻求戒烟支持的成年吸烟者,随机分为常规戒烟热线护理组或一个包含不同 NRT 产品(贴片、口香糖、吸入器、舌下片剂、口服袋)的盒子,在戒烟前尝试一周,然后选择其中一种或两种产品使用 8 周。
主要结局是戒烟后 6 个月时 7 天点流行率吸烟戒断率。次要结局包括连续戒烟率、吸烟量、戒断、NRT 选择和 1 周、3 周、3 个月和 6 个月时的严重不良事件。
两组之间 6 个月戒烟率(7 天点流行率或连续戒烟率)无差异。然而,分配到干预组的吸烟者更有可能在 3 个月时戒烟[自我报告的点流行率,相对风险(RR)=1.17,95%置信区间(CI):1.02,1.35,P=0.03],复发时间更长(中位数 70 天与 28 天,P<0.01),并且显著更多地使用 NRT。选择框概念受到使用者的高度认可,贴片和吸入器联合使用最受欢迎(34%)。
就 6 个月时的戒烟率而言,为有戒烟意愿的吸烟者免费提供广泛的尼古丁替代疗法,包括 1 周的熟悉期和最多两种产品的选择,与提供成本降低和无熟悉期的尼古丁替代疗法选择相比,没有明显差异。这项试验已在澳大利亚临床试验网络注册,编号为:ACTRN 12606000451505。