Reduced nicotine content cigarettes and use of alternative nicotine products: exploratory trial

Abstract

Aims: To compare the use of alternative nicotine products, smoking behavior and tobacco biomarker exposure in smokers unwilling to quit who were assigned randomly to normal nicotine content (NNC) cigarettes or very low nicotine content (VLNC) cigarettes.

Design: Randomized, parallel-arm 8-week study with assignment to VLNC (VLNC 1, n = 53) or NNC (NNC, n = 27) with access to non-cigarette combusted and non-combusted tobacco/nicotine products or to VLNC with access to only non-combusted products (VLNC2, n = 56).

Setting: Clinics in Minnesota, USA.

Participants: Smokers uninterested in quitting smoking with a mean [± standard deviation (SD)] age of 44 (± 14) years and smoking 16 (± seven) cigarettes/day; 51% female, 72% white.

Measurements: During the experimental period, the measures taken included: rate of alternative products used, amount of and abstinence from combusted tobacco used and tobacco exposure biomarkers.

Findings: There were higher rates of non-combusted alternative tobacco/nicotine product use in both VLNC conditions versus the NNC condition [rate ratio (RR) = 2.18, 95% confidence interval (CI) = 1.94, 2.46 and RR = 1.64, 95% CI = 1.46, 1.85, respectively] and in VLNC1 versus VLNC2 condition (RR = 1.33, 95% CI = 1.23, 1.44), accompanied by reduced biomarkers of exposure primarily in VLNC2 condition compared to NNC condition (Ps < 0.05). Fewer combusted products were smoked at almost all visits (Ps ≤ 0.02) and there were higher rates of abstinence for both VLNC conditions compared with the NNC condition (VLNC1 versus NNC: RR = 9.96, 95% CI = 5.01, 19.81; VLNC2 versus NNC: RR = 11.23, 95% CI = 5.74, 21.97).

Conclusion: The offer of, and instructions to use, reduced nicotine content cigarettes during an 8-week period led to greater use of alternative tobacco/nicotine products compared with continued use of normal nicotine cigarettes and also reductions in smoking rates.

Keywords: Alternative nicotine delivery systems; electronic cigarettes; exposure biomarkers; medicinal nicotine; nicotine regulation; product standards; reduced nicotine content cigarettes; smokeless tobacco.

© 2016 Society for the Study of Addiction.

Figures

Figure 1

Participant flow from screening to end of intervention.

Figure 2

Mean number of study cigarettes smoked/day across experimental conditions (VLNC1: Very Low Nicotine Content (VLNC) cigarettes with access to non-cigarette combusted and non-combusted tobacco/nicotine products; VLNC2: VLNC cigarettes with access to non-combusted tobacco/nicotine products only; NNC: normal nicotine content (NNC) cigarettes with access to non-cigarette combusted and non-combusted tobacco/nicotine products) during the 8-week intervention period. Significant difference compared with the NNC condition (+p<0.05, *p <0.01, **p<0.001) based on adjusted repeated measures analysis.

Figure 3

Percent use of alternative products in each of the experimental conditions (VLNC1: Very Low Nicotine Content (VLNC) cigarettes with access to non-cigarette combusted and non-combusted tobacco/nicotine products; VLNC2: VLNC cigarettes with access to non-combusted tobacco/nicotine products only; NNC: normal nicotine content (NNC) cigarettes with access to non-cigarette combusted and non-combusted tobacco/nicotine products) during the 8-week intervention period.

Figure 4

Mean number of combusted products used per day and carbon monoxide levels at each visit across experimental conditions (VLNC1: Very Low Nicotine Content (VLNC) cigarettes with access to non-cigarette combusted and non-combusted tobacco/nicotine products; VLNC2: VLNC cigarettes with access to non-combusted tobacco/nicotine products only; NNC: normal nicotine content (NNC) cigarettes with access to non-cigarette combusted and non-combusted tobacco/nicotine products). Baseline refers to ad libitum smoking of usual brand cigarettes. Significant differences compared with the NNC condition (+p<0.05 and *p=0.01) and compared with VLNC2 (#p<0.01) based on adjusted repeated measures analysis.