Complementing the Standard Multicomponent Treatment for Smokers With Denicotinized Cigarettes: A Randomized Trial

Abstract

Introduction: Standard treatments (STs) for smoking cessation typically combine pharmacotherapy and behavioral support but do not address the sensory and behavioral aspects of smoking which may play a role in maintaining smoking behavior. Replacing such sensations temporarily after cessation may enhance treatment efficacy. We hypothesized that denicotinized cigarettes (DNCs), which have a very low nicotine content but provide these sensory and behavioral stimuli, could help alleviate urges to smoke and tobacco withdrawal symptoms and in turn enhance the efficacy of ST.

Methods: Two hundred smokers seeking treatment received nine weekly behavioral support sessions and pharmacotherapy (100 used varenicline, 100 used nicotine replacement therapy). They were randomized on the target quit day to receive 280 DNCs (used ad libitum over 2 weeks in addition to ST) or ST alone.

Results: Urge-to-smoke frequency (2.61 vs. 2.96, P = .03) but not strength (2.85 vs. 3.10, P = .20) in the first week of abstinence was significantly lower in DNC users versus ST alone. There were no differences in composite withdrawal scores between groups. Abstinence was significantly higher among DNC users versus ST alone at 1 (OR = 2.07; 95% CI: 1.63% to 3.70%) and 4 weeks (OR = 1.83; 95% CI: 1.05% to 3.21%), but not at 12 weeks (OR = 1.42; 95% CI: 0.79% to 2.55%). DNC use was a significant predictor of abstinence at 1 and 4 weeks (OR = 2.63; 95% CI: 1.40% to 4.93% and OR = 2.38; 95% CI: 1.26% to 4.46%), but not at 12 weeks.

Conclusions: Adding DNCs to ST has the potential to assist smokers early in their quit attempt, but research is needed to determine how best to utilize DNCs in treatment.