Smoking Cessation in Highly Dependent Smokers with 4 mg Nicotine Polacrilex

The objective was to evaluate the efficacy of nicotine polacrilex 4 mg for smoking cessation in highly nicotine-dependent cigarette smokers defined by an expired carbon monoxide level of ≥ 15 ppm and a FTQ score of ≥7. The design was a multicenter, double-blind, randomized, parallel, 6-week clinical trial. 563 highly nicotine-dependent cigarette smokers were randomized to one of three treatment interventions, (a) placebo, (b) 2 mg, or (c) 4 mg nicotine polacrilex. Overall, patients assigned to the 4 mg treatment group had a 39% abstinence rate, compared to 33% and 30% quit rate for the 2 mg and placebo groups respectively (p = .191). Results indicate that, in compliant Ss (those using ≥9 pieces of medication/day), 56% of Ss in the 4 mg treatment group were abstinent, compared to 33% and 33% respectively, in the 2 mg and placebo groups (p = .0016). It was concluded that 4 mg nicotine polacrilex is an effective aid to smoking cessation in compliant, highly-dependent smokers.