Lisa M Fucito, Stephen R Baldassarri, Ran Wu, Ralitza Gueorguieva, Meghan E Morean, Roy S Herbst, Suchitra Krishnan-Sarin, Stephanie S O'Malley
{"title":"Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults.","authors":"Lisa M Fucito, Stephen R Baldassarri, Ran Wu, Ralitza Gueorguieva, Meghan E Morean, Roy S Herbst, Suchitra Krishnan-Sarin, Stephanie S O'Malley","doi":"10.1136/tc-2024-059094","DOIUrl":null,"url":null,"abstract":"<p><p>Oral nicotine pouches may have potential for smoking cessation, but scientific evidence on the effects of pouches and their constituents on smoking behaviour is limited.</p><p><strong>Design: </strong>This study was a 4-week, open-label, randomised pilot trial of nicotine pouches in 3 mg (low) or 6 mg (high) nicotine strength.</p><p><strong>Subjects: </strong>US outpatient research clinic with non-treatment seeking adults who smoke cigarettes (N=30).</p><p><strong>Interventions: </strong>Participants selected two flavours and were instructed to switch to using nicotine pouches in place of cigarettes.</p><p><strong>Main outcome measures: </strong>We compared groups on cigarettes smoked per day, pouch use and urinary levels of a tobacco-specific carcinogen (NNAL) over 4 weeks, biochemically verified 7-day point prevalence smoking abstinence at week 4, and willingness to continue pouch use.</p><p><strong>Results: </strong>Nearly all participants completed the trial (29/30). Participants in both groups significantly reduced their cigarettes smoked per day (log-transformed) over time (F<sub>3, 74.4</sub>=3.8, p=0.01). The 6 mg group reported numerically greater, but non-significant, reductions in smoking than the 3 mg group (least-square mean difference (LSMD) at week 1=0.008; 95% CI -0.42-0.44; LSMD at week 4=0.38; 95%<i> </i>CI -0.06-0.81). The 6 mg group also reported numerically higher, but non-significant, likelihood of complete smoking abstinence (13% vs 0%) and willingness to continue pouch use (67% vs 40%). There were no differences by group or time for NNAL.</p><p><strong>Conclusions: </strong>Results provide preliminary support for nicotine pouches for cigarette substitution. Compared with lower nicotine strength pouches, higher nicotine strength pouches may have a greater impact on smoking behaviour and adults who smoke may be more willing to use them.</p><p><strong>Trial registration number: </strong>NCT04250727.</p>","PeriodicalId":23145,"journal":{"name":"Tobacco Control","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tobacco Control","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/tc-2024-059094","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
Oral nicotine pouches may have potential for smoking cessation, but scientific evidence on the effects of pouches and their constituents on smoking behaviour is limited.
Design: This study was a 4-week, open-label, randomised pilot trial of nicotine pouches in 3 mg (low) or 6 mg (high) nicotine strength.
Subjects: US outpatient research clinic with non-treatment seeking adults who smoke cigarettes (N=30).
Interventions: Participants selected two flavours and were instructed to switch to using nicotine pouches in place of cigarettes.
Main outcome measures: We compared groups on cigarettes smoked per day, pouch use and urinary levels of a tobacco-specific carcinogen (NNAL) over 4 weeks, biochemically verified 7-day point prevalence smoking abstinence at week 4, and willingness to continue pouch use.
Results: Nearly all participants completed the trial (29/30). Participants in both groups significantly reduced their cigarettes smoked per day (log-transformed) over time (F3, 74.4=3.8, p=0.01). The 6 mg group reported numerically greater, but non-significant, reductions in smoking than the 3 mg group (least-square mean difference (LSMD) at week 1=0.008; 95% CI -0.42-0.44; LSMD at week 4=0.38; 95%CI -0.06-0.81). The 6 mg group also reported numerically higher, but non-significant, likelihood of complete smoking abstinence (13% vs 0%) and willingness to continue pouch use (67% vs 40%). There were no differences by group or time for NNAL.
Conclusions: Results provide preliminary support for nicotine pouches for cigarette substitution. Compared with lower nicotine strength pouches, higher nicotine strength pouches may have a greater impact on smoking behaviour and adults who smoke may be more willing to use them.
口服尼古丁袋可能具有戒烟的潜力,但关于尼古丁袋及其成分对吸烟行为的影响的科学证据有限。设计:本研究是一项为期4周的、开放标签的、随机的、尼古丁含量为3毫克(低)或6毫克(高)的尼古丁袋装试验。对象:美国门诊研究诊所非治疗寻求吸烟成人(N=30)。干预措施:参与者选择了两种口味,并被指示改用尼古丁袋代替香烟。主要结局指标:我们比较了各组在4周内的每日吸烟量、烟袋使用和尿中烟草特异性致癌物(NNAL)水平,第4周生化验证的7天点状戒烟率,以及继续使用烟袋的意愿。结果:几乎所有参与者都完成了试验(29/30)。随着时间的推移,两组参与者每天吸烟的数量都显著减少(对数转换)(F3, 74.4=3.8, p=0.01)。6毫克组报告的吸烟率比3毫克组减少的数值更大,但不显著(第1周的最小二乘平均差(LSMD) =0.008;95% ci -0.42-0.44;第4周LSMD =0.38;95% ci -0.06-0.81)。6毫克组也报告了更高的数字,但不显著,完全戒烟的可能性(13%对0%)和继续使用烟袋的意愿(67%对40%)。NNAL组间和时间间无差异。结论:研究结果为尼古丁袋替代卷烟提供了初步支持。与低尼古丁强度的烟袋相比,高尼古丁强度的烟袋对吸烟行为的影响可能更大,吸烟的成年人可能更愿意使用它们。试验注册号:NCT04250727。
期刊介绍:
Tobacco Control is an international peer-reviewed journal covering the nature and consequences of tobacco use worldwide; tobacco''s effects on population health, the economy, the environment, and society; efforts to prevent and control the global tobacco epidemic through population-level education and policy changes; the ethical dimensions of tobacco control policies; and the activities of the tobacco industry and its allies.