Lisa M Fucito, Stephen R Baldassarri, Ran Wu, Ralitza Gueorguieva, Meghan E Morean, Roy S Herbst, Suchitra Krishnan-Sarin, Stephanie S O'Malley
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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":"{\"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. 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引用次数: 0
摘要
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。
Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults.
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.
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.