Efficacy of a nicotine inhaler in smoking cessation: a double-blind, placebo-controlled trial

A non-combustible nicotine inhaler, administered orally, has been developed for treatment of smokers. The inhaler allows weaning from nicotine while maintaining partial reinforcement of the ritual/sensory phenomena of smoking. Subjects were randomly assigned to active (n = 112) and placebo (n = 111) groups. Some behavioral intervention occurred as a function of participation. Strict abstinence (primary outcome criterion) was defined by CO < or = 8 ppm with no slips allowed at any time and cotinine values < or = 14 at 1 year. Survival analysis showed active inhaler was superior to placebo (p < 0.01). Active vs. placebo success rates were: 63% vs. 47% (day 3), 46% vs. 28% (week 1), 36% vs. 19% (week 2), 33% vs. 16% (week 3), 29% vs. 14% (week 6), 24% vs. 10% (3 months), 17% vs. 9% (6 months) and 13% vs. 8% (1 year). chi 2 analyses were significant through 3 months but not at 6 months (p < 0.08) or 1 year. Craving was relieved with active inhalers at day 3 and week 1. Subjects averaged six inhalers/day. Cotinine levels were 57-61% of smoking levels. Common side effects included throat/mouth irritation and coughing. Failure was predicted by early slips. The inhaler is clearly useful for short-term smoking cessation with potential for long-term efficacy. Extended access to the inhaler and relapse prevention training could improve success rates. Another promising approach would be to combine the inhaler with a nicotine patch.