Nollen Nicole L, Cox Lisa Sanderson, Mayo Matthew S, Ellerbeck Edward F, Arnold Michael J, Salzman Gary, Shanks Denton, Woodward Jennifer, Greiner K Allen, Ahluwalia Jasjit S
Department of Population Health and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.
Department of Biostatistics & Data Science and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.
Contemp Clin Trials Commun. 2022 Nov 5;30:101032. doi: 10.1016/j.conctc.2022.101032. eCollection 2022 Dec.
The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality.
The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12.
If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke.
NCT03897439.
烟草治疗的标准护理方法是让吸烟的个体继续使用同一种戒烟药物，即使他们没有戒烟。另一种策略是根据无反应情况调整药物治疗。少数研究探讨了这种方法，但它们只调整了一次药物治疗，和/或关注的是在戒烟尝试失败后较远时间而非较近时间的调整。很少有研究纳入在戒烟方面成功率较低且承担着与烟草相关的发病率和死亡率不成比例份额的少数族裔。
本研究正在比较优化治疗（OPT）与强化常规护理（UC）对吸烟的非裔美国人（AA）戒烟的疗效。吸烟的非裔美国人（n = 392）按1:1随机分为OPT组或UC组。两组参与者均接受7次戒烟咨询以及18周的药物治疗，并随访至第26周。OPT组参与者接受尼古丁贴片，并根据第2周和第6周经一氧化碳验证的吸烟状态（≥6 ppm），对伐尼克兰和安非他酮加贴片进行多达两次的药物治疗调整。UC组参与者在整个治疗期间均接受贴片治疗。我们假设在第12周时，OPT在经生化验证的戒烟这一主要结局上比UC更有效。
如果有效，研究结果可能会拓宽烟草依赖治疗的范围，并推动该领域朝着改善吸烟的非裔美国人戒烟情况的优化策略发展。
NCT03897439。
