A DOUBLE-BLIND TRIAL OF A NICOTINE INHALER FOR SMOKING CESSATION

Objective.-To evaluate the efficacy of a new nicotine inhaler system for smoking cessation. Design.-A 1 -year, randomized, double-blind, placebo-controlled study. Setting.-Medical outpatient clinic with physicians experienced in smoking cessation assistance. Subjects.-A total of 286 volunteers who smoked at least 10 cigarettes daily recruited through a local newspaper. Intervention.-Subjects were randomly allocated to nicotine inhalers (n=l45) or placebo (n=l41) to be used for 3 months followed by tapering for 3 months in the context of minimal levels of advice and support. Main Outcome Measure.-Continuous smoking abstinence at weeks 6,12, 24, and 52, verified by measurements of carbon monoxide in expired air. Results.-Continuous smoking abstinence was significantly higher for the active nicotine inhaler group compared with the placebo inhaler group. The respective success rates were 28% and 12% after 6 weeks, 21% and 9% after 12 weeks, 17% and 8% after 6 months, and 15% and 5% after 1 year (P=.02 to .001). The mean nicotine substitution based on cotinine determinations after 2 weeks was 43% (SD, 45%) of smoking levels. The treatment was well tolerated, and no serious adverse events were reported. Conclusions.-In this setting the nicotine inhaler appeared safe to use and increased success rates of smoking cessation attempts.