Department of Public Health Sciences, Penn State College of Medicine, Pennsylvania State University, Hershey, PA.
Department of Psychiatry, Georgetown University, Washington, DC.
Nicotine Tob Res. 2021 May 24;23(6):992-1001. doi: 10.1093/ntr/ntaa247.
The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC).
A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation.
The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%).
This study supports a VLNC standard in cigarettes.
Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.
美国食品和药物管理局发布了一项关于制定香烟中尼古丁含量产品标准的预先通知，重点是最低或非成瘾性的极低尼古丁含量（VLNC）。
一项在美国宾夕法尼亚州赫尔希和华盛顿特区进行的为期 33 周、双臂、双盲随机试验纳入了每天至少吸 5 支香烟的成年烟民（每天≥5 支），且他们在接下来的六个月内没有戒烟计划。参与者被随机分配到减少尼古丁含量（RNC）研究香烟组或常规尼古丁含量（UNC）研究香烟组。RNC 研究组的香烟每三周逐渐减少到最终的 VLNC（0.2 毫克/支），持续六周；UNC 研究组的香烟则为常规尼古丁含量（11.6 毫克/支）。结果包括通过流失率（主要结果）、依从性、吸烟依赖性和烟草生物标志物的减少以及干预后的戒烟来衡量研究香烟的可接受性。
RNC（n = 122）组与 UNC（n = 123）组相比，流失率更高（调整后的危险比为 3.4；95%置信区间[CI]为 1.99 至 5.81）。在干预结束时，RNC 组的可替宁水平降低了 50%（平均组间差异为-137ng/ml；95%CI-172，-102）。RNC 组每天吸烟的支数减少了 4.1（95%CI-6.44，-1.75），一氧化碳水平降低了 4.0ppm（95%CI-7.7，-0.4）。47%（29/62）的 RNC 组在生化上符合吸食 VLNC 香烟的标准（平均可替宁水平为 8.9ng/ml）。在三个月的随访中，只有依从性 VLNC 吸烟者通过辅助戒烟尝试戒烟（N = 6/22，27%）。
这项研究支持在香烟中设定 VLNC 标准。
差异性的脱落和不依从性表明，一些吸烟者在过渡到低尼古丁香烟时存在困难。如果建立尼古丁减少标准，这些吸烟者将从药用或非燃烧烟草产品中的补充尼古丁中受益。其他吸烟者成功地过渡到极低尼古丁含量的香烟，并大大减少了尼古丁的摄入量。
