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 = 145) or placebo (n = 141) 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.[1]References
- A double-blind trial of a nicotine inhaler for smoking cessation. Tønnesen, P., Nørregaard, J., Mikkelsen, K., Jørgensen, S., Nilsson, F. JAMA (1993) [Pubmed]
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