Sustained effects of reduced nicotine cigarettes and co-use of non-combusted alternative nicotine delivery systems: A one-month follow-up to a randomized clinical trial.

INTRODUCTION: The US FDA has proposed a nicotine-reducing standard for cigarettes. A recent trial found that, with access to alternative nicotine delivery systems (ANDS; i.e., e-cigarettes, nicotine medicines), participants randomized to very low nicotine content (VLNC) vs normal nicotine content (NNC) cigarettes achieved greater smoking reduction. This secondary analysis compared effects of the VLNC+ANDS-access versus NNC+ANDS-access conditions on post-intervention cigarette smoking. METHODOLOGY: Adults who smoke were randomized to 12 weeks of an experimental marketplace with VLNC (0.4mg nicotine/gram tobacco) vs NNC (15.8mg/g) cigarettes. All participants had access to non-combusted ANDS. Multivariable regressions were used to examine effects of VLNC vs NNC condition and co-use of ANDS with cigarettes on smoking and cessation-related outcomes during follow-up, when no study products were provided (weeks 12-16). RESULTS: Among those who completed follow-up (n = 336), VLNC vs NNC participants achieved more 7-day point-prevalence smoking abstinence (VLNC=19.6 % vs NNC=11.0 %; p = 0.031), had more smokefree days (VLNC mean=9.7 vs NNC mean=4.9; p = 0.043), and smoked fewer cigarettes/day (VLNC mean=7.3 vs NNC mean=10.7; p < 0.001). Among participants smoking at week-12 (n = 281), co-use of ANDS vs exclusive smoking was associated with more quit attempts (25.5 % vs 13.0 %; p = 0.005) and fewer cigarette/day (mean=9.3 vs mean=12.4; p < 0.001) during follow-up. CONCLUSIONS: Switching to VLNC cigarettes with access to non-combusted ANDS produced sustained effects on smoking abstinence. Among those who continued smoking, co-use of ANDS was associated with fewer cigarettes/day and more attempts to quit. Findings provide further support for a nicotine-reducing standard for cigarettes in the context of a marketplace which includes ANDS.

Duke Scholars

Author F Joseph McClernon Psychiatry & Behavioral Sciences, Behavioral Medicine & Neur ...