Caponnetto Pasquale, Spicuzza Lucia, Campagna Davide, Ahluwalia Jasjit S, Russell Christopher, Maglia Marilena, Riela Paolo Marco, Longo Carmelo Fabio, Caci Grazia, Quattropani Maria Catena, Signorelli Maria Salvina, Polosa Riccardo
Department of Science of Education, Section of Psychology, University of Catania, Italy.
Centre of Excellence for the Acceleration of HArm Reduction (CoEHAR), University of Catania, Italy.
EClinicalMedicine. 2023 Nov 21;66:102316. doi: 10.1016/j.eclinm.2023.102316. eCollection 2023 Dec.
The efficacy and safety of varenicline for smoking cessation among individuals who smoke tobacco cigarettes and also use electronic cigarettes (known e-cigarettes or vapes) have not been studied. We aimed to address this knowledge gap and examine predictors for smoking abstinence.
In this double-blind, placebo-controlled, single-centre randomised trial in Italy, we enrolled adults who had used an e-cigarette daily for at least 12 months and who also smoked at least one tobacco cigarette per day and had a willingness to quit smoking. 155 participants were randomly assigned to receive either varenicline (n = 78) or matched placebo (n = 77). Varenicline (1 mg, administered twice daily for 12 weeks) was given in combination with smoking cessation counseling in dual users with an intention to quit smoking. Participants in both treatment groups received the same smoking cessation counselling throughout the whole duration of the study. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up. The primary efficacy endpoint was continuous abstinence rate (CAR) in weeks 4-12. Secondary efficacy endpoints were the CAR in weeks 4-24 and 7-day point prevalence of smoking abstinence at weeks 12 and 24. This study is registered in EUDRACT, 2016-000339-42.
Between November 2018, and February 2020, 114 participants (61 in the varenicline group and 53 in the placebo group) completed the intervention phase at week 12 and 88 participants (52 in the varenicline group and 36 in the placebo group) completed the follow-up phase at week 24. CARs were significantly higher for the varenicline vs placebo at each time-point: 50.0% vs 16.9% (OR = 4.9; 95% CI, 2.3-10.4; P < 0.0001) between weeks 4 and 12; and 48.7% vs 14.3% (OR = 5.7; 95% CI, 2.6-12.3; P < 0.0001) between weeks 4 and 24. The 7-day point prevalence of smoking abstinence was also higher for the varenicline than placebo at each time point. Adverse events were rated as mild or moderate and rarely led to treatment discontinuation.
Our findings indicate that inclusion of varenicline in a cessation programme for adults who smoke and use e-cigarettes with an intention to quit smoking could result in smoking abstinence without serious adverse events. In the absence of evidence from other smoking cessation methods, it could be useful to suggest the use of varenicline in cessation programmes specifically designed to help dual users stop smoking. Further research in larger and more generalisable populations is required to strengthen such a suggestion.
Global Research Award for Nicotine Dependence, an independently reviewed competitive grants programmeme funded by Pfizer.
伐尼克兰用于既吸食烟草香烟又使用电子烟（已知的电子烟或蒸汽烟）的个体戒烟的疗效和安全性尚未得到研究。我们旨在填补这一知识空白，并研究戒烟的预测因素。
在意大利进行的这项双盲、安慰剂对照、单中心随机试验中，我们招募了每天使用电子烟至少12个月、每天至少吸食一支烟草香烟且有戒烟意愿的成年人。155名参与者被随机分配接受伐尼克兰（n = 78）或匹配的安慰剂（n = 77）。伐尼克兰（1毫克，每日两次，给药12周）与戒烟咨询相结合，用于有戒烟意愿的双重使用者。两个治疗组的参与者在整个研究期间接受相同的戒烟咨询。试验包括一个12周的治疗阶段，随后是一个12周的随访阶段。主要疗效终点是第4至12周的持续戒烟率（CAR）。次要疗效终点是第4至24周的CAR以及第12周和第24周7天的戒烟点患病率。本研究已在欧盟临床试验注册数据库（EUDRACT）注册，注册号为2016 - 000339 - 42。
在2018年11月至2020年2月期间，114名参与者（伐尼克兰组61名，安慰剂组53名）在第12周完成了干预阶段，88名参与者（伐尼克兰组52名，安慰剂组36名）在第24周完成了随访阶段。在每个时间点，伐尼克兰组的CAR均显著高于安慰剂组：第4至12周为50.0% 对16.9%（OR = 4.9；95%CI，2.3 - 10.4；P < 0.0001）；第4至24周为48.7% 对14.3%（OR = 5.7；95%CI，2.6 - 12.3；P < 0.0001）。在每个时间点，伐尼克兰组的7天戒烟点患病率也高于安慰剂组。不良事件被评为轻度或中度，很少导致治疗中断。
我们的研究结果表明，在针对既吸烟又使用电子烟且有戒烟意愿的成年人的戒烟计划中加入伐尼克兰，可能会实现戒烟且无严重不良事件。在缺乏其他戒烟方法证据的情况下，建议在专门设计用于帮助双重使用者戒烟的戒烟计划中使用伐尼克兰可能是有用的。需要在更大规模且更具普遍性的人群中进行进一步研究以加强这一建议。
尼古丁依赖全球研究奖，由辉瑞公司资助的一项经过独立评审的竞争性资助项目。
