Jansen Kelley J, Tranby Brianna N, Shane Aliassa L, Takeno Todd, Chadwick Kelly, Sinicrope Pamela, Shaw Jennifer L, Tyndale Rachel F, Harris Jeffrey R, Patten Christi A, Avey Jaedon P
Center for Alaska Native Health Research, University of Alaska Fairbanks, 2141 Koyukuk Dr, Fairbanks, AK, 99775, USA.
Southcentral Foundation Research Department, 4085 Tudor Centre Drive, Anchorage, Alaska, 99508, USA.
Arch Public Health. 2024 Aug 22;82(1):129. doi: 10.1186/s13690-024-01365-7.
Individualized treatment for commercial tobacco smoking cessation, such as through the utilization of the nicotine metabolite ratio (NMR), offers potential clinical benefit. NMR is a metabolism-informed biomarker that can be used to guide medication selection. NMR testing is particularly promising for tobacco cessation efforts in populations with high rates of smoking, such as some Alaska Native and American Indian (AN/AI) communities. To date, no prior study has evaluated the implementation of NMR-guided tobacco cessation with AN/AI populations.
The present "QUIT" protocol is a two-phase study that will occur at Southcentral Foundation (SCF), an Alaska Native-owned health system, serving 70,000 AN/AI people, based in Anchorage, Alaska. In Phase one, qualitative interviews with customer-owners (patients), providers and administrators (n = 36) and a 10-participant beta-test will be used to refine a strategy to implement NMR testing in the health system. Phase two will involve a single-arm pilot trial (n = 50) and qualitative interviews throughout data collection (n = 48) to evaluate the implementation strategy and explore the real-world acceptability and feasibility of NMR testing to guide tobacco cessation with AN/AI populations.
This study utilizes a community-based participatory approach to refine and implement a nicotine metabolism-informed smoking cessation program in a Tribal healthcare setting. The process and findings from this study will reflect the importance of customer-owner choice and honor the lived experience involved in quitting commercial tobacco. Pilot study data will inform the effect and sample sizes required for a future pragmatic trial of NMR-guided smoking cessation.
This study will be registered with clinicaltrials.gov after the beta test is complete and the final IRB protocol is approved.
针对商业烟草戒烟的个体化治疗，例如通过利用尼古丁代谢物比率（NMR），具有潜在的临床益处。NMR是一种基于代谢的生物标志物，可用于指导药物选择。NMR检测对于吸烟率较高的人群（如一些阿拉斯加原住民和美国印第安人（AN/AI）社区）的戒烟工作特别有前景。迄今为止，尚无先前的研究评估在AN/AI人群中实施NMR指导的戒烟情况。
当前的“戒烟”方案是一项两阶段研究，将在位于阿拉斯加安克雷奇的阿拉斯加原住民拥有的医疗系统——中南部基金会（SCF）开展，该系统为70000名AN/AI人群提供服务。在第一阶段，将对客户（患者）、提供者和管理人员（n = 36）进行定性访谈，并进行10名参与者的预测试，以完善在医疗系统中实施NMR检测的策略。第二阶段将包括一项单臂试点试验（n = 50）以及在整个数据收集过程中进行定性访谈（n = 48），以评估实施策略，并探索NMR检测指导AN/AI人群戒烟在现实世界中的可接受性和可行性。
本研究采用基于社区的参与式方法，在部落医疗环境中完善并实施基于尼古丁代谢的戒烟计划。本研究的过程和结果将反映客户选择的重要性，并尊重戒除商业烟草过程中的实际经历。试点研究数据将为未来NMR指导戒烟的实用试验所需的效果和样本量提供参考。
本研究将在预测试完成且最终的机构审查委员会方案获得批准后在clinicaltrials.gov上注册。
