EFFICACY OF A NICOTINE NASAL SPRAY IN SMOKING CESSATION - A PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL

Laboratory trials have demonstrated the efficacy of nicotine replaceme nt in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting an d passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-administered relief from cigarette withdrawal. The NNS wa s tested for safety and efficacy in smoking cessation. Two hundred and fifty-five smokers were randomized to NNS or a piperine placebo. Drug use was limited to 8-32 doses/day for 6 months. Subjects were tested while smoking and at post-cessation daily (week 1) with follow-up at w eeks 2, 3, 6 and at 3 months, 6 months and I year. Continuous abstinen ce analyses (CO less than or equal to 8 ppm.; no slips) showed that NN S significantly enhanced success rates over placebo overall (p < 0.001 ) and at all test intervals. Differences at key intervals between acti ve and placebo were: 63% vs. 40% (day 5), 51% us. 30% (week 3), 43% vs . 20% (6 weeks), 34% vs. 13% (3 months), 25% vs. 10% (6 months) and 18 % vs. 8% (I year). Side effects were common but tolerable. Cotinine me asures showed that replacement of nicotine approximated 30% of smoking levels. Hazard functions revealed relapse risks peaked at day 1, day 5 and 3 weeks for strict abstinence. It is concluded NNS is safe, effi cacious and a viable alternative treatment for smoking cessation.