The Impact of Reducing Nicotine Content on Adolescent Cigarette Smoking and Nicotine Exposure: Resul

Cassidy RN, Tidey JW, Jackson KM, et al.
The Impact of Reducing Nicotine Content on Adolescent Cigarette Smoking and Nicotine Exposure: Results from a Randomized Controlled Trial.
[published online ahead of print, 2022 Dec 9]. Nicotine Tob Res. 2022;ntac279. doi:10.1093/ntr/ntac279

Introduction. As the science base around the potential benefits of a reduced-nicotine standard for cigarettes grows, information on the potential effects on adolescent smokers is a high priority. The aim of this randomized trial was to test the influence of three-week exposure to reduced nicotine cigarettes in a sample of adolescent daily smokers.
Methods. In this double-blind, two-arm, randomized controlled trial (NCT0258731), following a one-week baseline, adolescent daily smokers not currently intending to quit (ages 15-19, n=66 randomized) were urn randomized to use either very low nicotine content (VLNC; 0.4 mg/g; n=33) or normal nicotine content (NNC, 15.8 mg/g; n=33) research cigarettes for three weeks. Participants attended 5 study sessions at our clinical laboratory. The primary outcome was average total cigarettes smoked per day (CPD; including both study and non-study cigarettes) at week 3.
Results. Stepwise regression results demonstrated that compared with NNC cigarettes (n=31), assignment to VLNC cigarettes (n=29), was associated with 2.4 fewer CPD on average than NNC assignment (p<.05).week 3 when controlling for covariates (p<.01, Cohen's d= 0.52 n=60 completed all procedures). VLNC cigarettes were also associated with lower levels of craving reduction than NNC cigarettes (QSU Factor 2, p<.05). No group differences were found for secondary outcomes.
Conclusions. Adolescent participants assigned to VLNC use for 3 weeks smoked fewer total cigarettes smoked per day relative to the NNC group. Overall, data suggest that a VLNC policy would reduce cigarette smoking in adolescents who smoke, but high rates of incomplete adherence that youth may seek alternative sources of nicotine in this scenario.
Implications. The US Food and Drug Administration may enact a reduced-nicotine product standard that would affect all commercially-available cigarettes. One important population affected by this policy would be adolescents who smoke. This study, the first clinical trial of very low nicotine content (VLNC) cigarettes in adolescents, demonstrates that adolescents switched to VLNC cigarettes for three weeks reduced their cigarettes smoked per day relative to the normal-nicotine cigarette control group, without leading to increased respiratory symptoms or increased withdrawal. Biomarkers indicated use of other sources of nicotine, suggesting that such a policy will need to consider approaches to assist in transitioning away from smoking.