Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence: A Randomized Clinical Trial.
Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence: A Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2022.41731
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发表时间：
2022-11-01
影响因子：
13.8
通讯作者：
Mahoney, Martin C.
中科院分区：
文献类型：
--
作者：
Hawk, Larry W., Jr.;Tiffany, Stephen T.;Colder, Craig R.;Ashare, Rebecca L.;Wray, Jennifer M.;Tyndale, Rachel F.;Brandon, Thomas H.;Mahoney, Martin C.
延长伐尼克兰戒烟前治疗的持续时间是否可以提高戒烟率？在这项纳入 320 名成年人的随机临床试验中，治疗结束时，接受延长治疗的参与者 (39%) 经生物验证的连续 4 周禁欲的百分比与标准 (36%) 磨合伐尼克兰相比并没有显着更高。这些研究结果表明，在每天吸烟的成年吸烟者中，将戒烟前伐尼克兰治疗的持续时间延长到标准的 1 周磨合期之后并没有显着提高持续戒烟率。这项随机临床试验检验了以下假设：在单个研究中心的成人中，延长磨合伐尼克兰治疗可能比标准伐尼克兰治疗产生更好的戒烟率。即使使用伐尼克兰（伐尼克兰）这种治疗烟草依赖的主要单一疗法，戒烟率仍然很低。初步证据表明，在戒烟前延长伐尼克兰治疗的持续时间可能会提高戒烟率。检验以下假设：与标准伐尼克兰磨合治疗（戒烟前 1 周）相比，延长伐尼克兰磨合治疗（戒烟前 4 周）可减少目标戒烟日期 (TQD) 之前的吸烟暴露并增强戒烟效果，尤其是在女性中。这项双盲、随机、安慰剂对照临床试验于 2017 年 10 月 2 日至 2020 年 12 月 9 日在纽约州布法罗的一个单中心研究诊所招募了参与者。在 1385 名接受筛查的人中，有 320 名每天吸 5 支或以上香烟 (CPD) 的成年人被随机分配并随访 28 周。数据分析时间为 2021 年 8 月至 2022 年 6 月。在 TQD 前阶段（第 1-4 周），延长磨合组接受 4 周的伐尼克兰治疗；标准磨合组接受 3 周的安慰剂治疗，随后接受 1 周的伐尼克兰治疗。两组患者在第 5 至 15 周期间均接受开放标签伐尼克兰治疗，并在 6 次就诊时接受简短的戒烟咨询。主要结局包括经过可替宁验证（治疗结束时 [EOT]）的自我报告在治疗的最后 4 周内持续戒烟（在 CPD 中）。次要结局包括生物验证的 6 个月随访中持续戒烟的自我报告以及戒烟前期间（第 1 周与第 4 周）自我报告的吸烟率下降百分比。共有 320 名参与者被随机分配，其中包括 179 名女性 (55.9%) 和 141 名男性 (44.1%)，平均 (SD) 年龄为 53.7 (10.1) 岁。与标准磨合组（157 人中的 57 人 [36.3%]）相比，延长磨合组（163 人中的 64 人 [39.3%]）在治疗最后 4 周（第 12-15 周；EOT）期间的持续戒断率并没有更高；比值比 [OR], 1.13 [95% CI, 0.72-1.78]），假设的情况也没有增加。组 × 性别相互作用显着（OR， 0.52 [95% CI，0.21-1.28]）。在 6 个月的随访中，连续禁欲也获得了类似的无显着性结果。与标准磨合组（−17.5% [2.7%]）相比，延长磨合组（−38.8% [2.8%]）戒烟前自我报告吸烟率的平均（SE）下降幅度更大。在每日吸烟的成年吸烟者中，将戒烟前伐尼克兰治疗的持续时间延长到标准的 1 周磨合期以上可以减少戒烟前的吸烟暴露，但更重要的是，并没有显着提高持续戒烟率。 ClinicalTrials.gov 标识符：NCT03262662
Does extending the duration of prequit treatment with varenicline improve rates of smoking abstinence? In this randomized clinical trial that included 320 adults, the percentage of bioverified continuous 4-week abstinence among participants at the end of treatment was not significantly greater among participants receiving extended (39%) compared with standard (36%) run-in varenicline. These findings show that among adult daily smokers, extending the duration of prequit varenicline treatment beyond the standard 1-week run-in period did not significantly improve continuous abstinence rates. This randomized clinical trial tests the hypothesis that extended run-in varenicline treatment may produce better smoking abstinence rates than standard varenicline therapy among adults in a single research site. Even with varenicline, the leading monotherapy for tobacco dependence, smoking abstinence rates remain low. Preliminary evidence suggests that extending the duration of varenicline treatment before quitting may increase abstinence. To test the hypotheses that, compared with standard run-in varenicline treatment (1 week before quitting), extended run-in varenicline treatment (4 weeks before quitting) reduces smoking exposure before the target quit date (TQD) and enhances abstinence, particularly among women. This double-blind, randomized, placebo-controlled clinical trial enrolled participants from October 2, 2017, to December 9, 2020, at a single-site research clinic in Buffalo, New York. Of 1385 people screened, 320 adults reporting smoking 5 or more cigarettes per day (CPD) were randomized and followed up for 28 weeks. Data were analyzed from August 2021 to June 2022. In the pre-TQD period (weeks 1-4), the extended run-in group received 4 weeks of varenicline; the standard run-in group received 3 weeks of placebo followed by 1 week of varenicline. Both groups received open-label varenicline during weeks 5 to 15 and brief quit counseling at 6 clinic visits. The primary outcome consisted of cotinine-verified (at end of treatment [EOT]) self-reported continuous abstinence from smoking (in CPD) during the last 4 weeks of treatment. Secondary outcomes included bioverified self-report of continuous abstinence at the 6-month follow-up and percentage of reduction in self-reported smoking rate during the prequit period (week 1 vs week 4). A total of 320 participants were randomized, including 179 women (55.9%) and 141 men (44.1%), with a mean (SD) age of 53.7 (10.1) years. Continuous abstinence during the final 4 weeks of treatment (weeks 12-15; EOT) was not greater in the extended run-in group (64 of 163 [39.3%]) compared with the standard run-in group (57 of 157 [36.3%]; odds ratio [OR], 1.13 [95% CI, 0.72-1.78]), nor was the hypothesized group × sex interaction significant (OR, 0.52 [95% CI, 0.21-1.28]). Similar nonsignificant results were obtained for continuous abstinence at the 6-month follow-up. The mean (SE) decrease in self-reported smoking rate during the prequit period was greater in the extended run-in group (−38.8% [2.8%]) compared with the standard run-in group (−17.5% [2.7%]). Among adult daily smokers, extending the duration of prequit varenicline treatment beyond the standard 1-week run-in period reduced prequit smoking exposure but, more importantly, did not significantly improve continuous abstinence rates. ClinicalTrials.gov Identifier: NCT03262662
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影响因子：
120.7
作者：
Baker, Timothy B.;Piper, Megan E.;Fiore, Michael C.
通讯作者：
Fiore, Michael C.
影响因子：
--
作者：
Hajek, Peter;McRobbie, Hayden J.;Dhanji, Al-Rehan
通讯作者：
Dhanji, Al-Rehan
影响因子：
1.4
作者：
Cahill, Kate;Stead, Lindsay F.;Polonio, Igor Bastos
通讯作者：
Polonio, Igor Bastos
影响因子：
4.7
作者：
Hawk, Larry W., Jr.;Ashare, Rebecca L.;Mahoney, Martin C.
通讯作者：
Mahoney, Martin C.
DOI：
10.1001/jama.2015.280
发表时间：
2015-02-17
期刊：
JAMA
影响因子：
--
作者：
Ebbert JO;Hughes JR;West RJ;Rennard SI;Russ C;McRae TD;Treadow J;Yu CR;Dutro MP;Park PW
通讯作者：
Park PW