Secondary Analysis of a Randomized Clinical Trial of Very Low Nicotine Cigarettes: Outcomes Across Social and Demographic Groups
Abstract
Objective: To examine whether the impact of a nicotine reduction standard (NRS) varies by socio-demographics. Methods: Secondary analysis of a 12-week trial (2018–2022) with 438 people who smoke (PWS) comparing very low nicotine content (VLNC) vs. normal nicotine content (NNC) cigarettes. Moderation by education, race, and age on cigarettes per day (CPD), smoke-free days, and biomarkers (CEMA, NNAL) was assessed using interaction models. Results: For race and education, interaction tests for moderation were not significant (ps>0.05). In subgroup analyses, VLNC condition reduced CPD and biomarkers and increased smoke-free days with the following exception: no difference in CEMA was observed by condition among those of lower education (Geometric mean ratio [GMR] = 0.72, 95% confidence interval [CI] = 0.39, 1.33). For age, multiple interaction tests were significant. In subgroup analyses, older but not younger adults, had no VLNC vs. NNC differences for CEMA (GMR: 0.85 [CI = 0.51, 1.41] vs 0.47 [CI = 0.35, 0.62]) or smoke-free days (rate ratio: 1.85 [CI = 0.63, 5.55] vs 5.85 [CI = 3.12, 10.89]). Conclusion: Age and potentially education moderate NRS effects among PWS. Policy Implications: Targeted support for older adults and those with lower education may maximize NRS benefits. Trial registration: NCT03272685
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 438 participants or records.
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