Lin Wenxue, Krebs Nicolle M, Zhu Junjia, Horn Kimberly, Foulds Jonathan, Evins A Eden, Muscat Joshua E
Department of Epidemiology and Biostatistics, College of Public Health, Temple University, Philadelphia, PA, 19122, USA.
Department of Public Health Sciences, College of Medicine, Pennsylvania State University, Hershey, PA, 17033, USA.
J Racial Ethn Health Disparities. 2024 Sep 4. doi: 10.1007/s40615-024-02155-1.
Tobacco regulatory policies are generally intended to apply to all segments of the population and to be equitable. Results from clinical trials on switching from commercial cigarettes to reduced nicotine cigarettes have included black populations but race-specific findings are not widely reported.
Data were pooled from two parallel randomized controlled trials of gradually reduced nicotine in cigarettes from 11.6 mg per cigarette down to 0.2 mg nicotine (very low nicotine content; VLNC) vs. usual nicotine content (UNC) cigarettes (11.6 mg) over an 18-week period in smokers with low socioeconomic status (SES) and mental health conditions, respectively. We used linear regression to determine the potential effects of cigarettes and biomarker reductions (blood cotinine and exhaled carbon monoxide) when using VLNC study cigarettes. An intention-to-treat (ITT) analysis included all randomized participants regardless of adherence to the protocol. A secondary compliance analysis compared control subjects (11.6 mg cigarettes) only to those switched to low nicotine cigarettes who were biochemically determined to be compliant to exclusively using VLNC cigarettes.
Both Black and White VLNC smokers had significantly lower plasma cotinine and exhaled carbon monoxide compared to those randomized to UNC cigarettes. The treatment × race interaction term was not significant for the outcome measures in both the ITT and secondary compliance analyses, except for cotinine in the ITT analysis (Whites: - 190 ng/mL vs. Blacks: - 118 ng/mL; p = 0.05).
A reduced nicotine regulation for cigarettes would result in substantial reduction in exposure to nicotine and toxicants in Black and White smokers.
烟草监管政策通常旨在适用于所有人群并确保公平。从商业香烟转向低尼古丁香烟的临床试验结果涵盖了黑人人群，但针对特定种族的研究结果并未广泛报道。
数据来自两项平行随机对照试验，在18周内，分别针对社会经济地位较低（SES）且有心理健康问题的吸烟者，将香烟中的尼古丁含量从每支11.6毫克逐渐降低至0.2毫克（极低尼古丁含量；VLNC），并与常规尼古丁含量（UNC）香烟（11.6毫克）进行对比。我们使用线性回归来确定使用VLNC研究香烟时香烟和生物标志物减少（血液可替宁和呼出一氧化碳）的潜在影响。意向性分析（ITT）包括所有随机分组的参与者，无论其是否遵守方案。二次依从性分析仅将对照组受试者（11.6毫克香烟）与那些转为低尼古丁香烟且经生化测定完全遵守仅使用VLNC香烟的受试者进行比较。
与随机分配到UNC香烟组的吸烟者相比，黑人和白人VLNC吸烟者的血浆可替宁和呼出一氧化碳水平均显著降低。在ITT分析和二次依从性分析中，除了ITT分析中的可替宁外，治疗×种族交互项对于各项结局指标均无显著意义（白人：-190纳克/毫升，黑人：-118纳克/毫升；p = 0.05）。
降低香烟尼古丁含量的监管措施将大幅减少黑人和白人吸烟者接触尼古丁和有毒物质的量。
