National Drug and Alcohol Research Centre, University of New South Wales, R1 Building, 22-32 King St, Randwick, Sydney, NSW, Australia.
Centre for Health Economics, Monash Business School, Monash University, Caufield, Australia.
Trials. 2022 Sep 14;23(1):777. doi: 10.1186/s13063-022-06644-8.
In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]-gum or lozenge) for smoking cessation.
This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated.
Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group.
Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021. https://www.anzctr.org.au.
在澳大利亚，吸烟率有所下降，但仍存在不平等现象，社会经济地位较低的人群吸烟率明显更高。临床试验数据表明，蒸发尼古丁产品（VNPs）有助于戒烟。大多数 VNP 试验都使用可再填充的罐系统，但新一代（pod）设备现在占据了最大的市场份额，但关于安全性和有效性的临床试验证据有限。本研究评估了与尼古丁替代疗法（[NRT]-口香糖或含片）相比，VNPs（pod 和罐设备）在戒烟方面的有效性、安全性和成本效益。
这是一项两臂、开放性、优效性、平行组、随机对照试验（RCT），采用分配隐藏和盲法结局评估。该 RCT 在澳大利亚悉尼新南威尔士大学国家药物和酒精研究中心进行。参与者为每天吸烟、有戒烟意愿且领取政府养老金或津贴的人群（N=1058）。参与者将按照 1:1 的比例随机（1:1 比例）分配，接受 8 周的免费治疗：VNPs，含有 pod（40mg/mL 尼古丁盐）和罐设备（18mg/mL 游离碱尼古丁）的混合口味；或 NRT（口香糖或含片；4mg）。所有参与者将在 5 周内每天收到短信行为支持。基线时通过电话进行评估，在第一个月内进行三次随访（两次检查电话和最终随访在随机分组后 7 个月），以确定吸烟状况、治疗依从性和不良事件。主要结局是 7 个月随访时通过≤5ppm 的一氧化碳呼气测试验证的 6 个月持续戒烟。还将评估 VNP 与 NRT 的安全性和成本效益。
需要进一步的数据来加强 VNP 帮助戒烟的证据确定性，特别是对于新一代 pod 设备。据我们所知，这是首次提供 VNP 选择的试验，并且对于新的 pod 设备，没有比较有效性试验数据。如果有效，结果可以为更广泛地实施 VNP 以帮助优先群体戒烟提供信息。
澳大利亚新西兰临床试验注册 ACTRN12621000076875。于 2021 年 1 月 29 日注册。https://www.anzctr.org.au。
