背景:吸烟是发病率和死亡率的主要原因。对于吸烟且不能或不会戒烟的成年人,无烟产品,比如尼古丁袋,已被认为是吸烟燃烧香烟的潜在替代品,以减少吸烟造成的危害。这些无烟产品中的香料在减少烟草危害方面的作用尚未得到充分理解。
目的:本研究评估了在自然环境中吸烟的成年人中,尼古丁袋产品(研究产品)中的香料对减少吸烟的影响。
方法:本研究采用序贯,多重赋值,随机试验设计。大约400名吸烟的合格成年人将被登记并随机分配,以便只能使用原始的(无味的)尼古丁袋产品或完整的风味特征(即,Berry,肉桂,柑橘,咖啡,薄荷,Original,和冬青)。尼古丁小袋产品。3周后,仅原始手臂的参与者将再次随机分配,其中一半保留在原始的唯一手臂中,另一半可以再获得3周的完整风味特征。主要结果是过期空气一氧化碳(CO)水平。次要结果是自我报告的香烟消费和CO验证的香烟禁欲。
结果:招聘和数据收集始于2023年9月,预计将持续到2025年3月。我们预计在2025年完成数据分析。截至2024年5月,我们已经招募了314名参与者。
结论:这项研究将提供有关无烟产品中的风味可用性可能对减少吸烟的影响的经验证据。
背景:ClinicalTrials.govNCT06072547;https://clinicaltrials.gov/study/NCT06072547。
■DERR1-10.2196/56565。
BACKGROUND: Cigarette smoking is a leading cause of morbidity and mortality. For adults who smoke cigarettes and cannot or will not quit smoking, smoke-free products, such as nicotine pouches, have been recognized as a potential alternative to smoking combusted cigarettes to reduce harm due to cigarette smoking. The role of flavors in these smoke-free products in tobacco harm reduction has not been fully understood.
OBJECTIVE: This
study evaluates the effect of flavors in on! nicotine pouch products (research products) in the reduction of cigarette smoking among adults who smoke cigarettes in their natural environment.
METHODS: This
study uses a sequential, multiple assignment, randomized
trial design. Approximately 400 eligible adults who smoke cigarettes will be enrolled and randomized to have access to either the Original (unflavored) on! nicotine pouch product only or a complete flavor profile (ie, Berry, Cinnamon, Citrus, Coffee, Mint, Original, and Wintergreen) of on! nicotine pouch products. After 3 weeks, participants in the Original-only arm will be randomized again, with half remaining in the Original-only arm and half having access to the complete flavor profile for another 3 weeks. Primary outcomes are expired-air carbon monoxide (CO) levels. Secondary outcomes are self-reported cigarette consumption and CO-verified cigarette abstinence.
RESULTS: Recruitment and data collection started in September 2023 and is projected to last until March 2025. We anticipate completing the data analysis in 2025. As of May 2024, we have enrolled 314 participants.
CONCLUSIONS: This
study will provide empirical evidence about the effect that flavor availability in smoke-free products may have in reducing cigarette smoking.
BACKGROUND: ClinicalTrials.gov NCT06072547; https://clinicaltrials.gov/
study/NCT06072547.
UNASSIGNED: DERR1-10.2196/56565.