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.