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

A non-combustible nicotine inhaler, administered orally, has been deve loped for treatment of smokers. The inhaler allows weaning from nicoti ne while maintaining partial reinforcement of the ritual/sensory pheno mena of smoking. Subjects were randomly assigned to active (n = 112) a nd placebo (n = 111) groups. Some behavioral intervention occurred as a function of participation. Strict abstinence (primary outcome criter ion) was defined by CO less than or equal to 8 ppm with no slips allow ed at any time and cotinine values less than or equal to 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% v s. 8% (1 year). chi(2) analyses were significant through 3 months but not at 6 months (p < 0.08) or I year. Craving was relieved with active inhalers at day 3 and week 1. Subjects averaged six inhalers/day. Cot inine levels were 57-61% of smoking levels. Common side effects includ ed throat/mouth irritation and coughing. Failure was predicted by earl y slips. The inhaler is clearly useful for short-term smoking cessatio n with potential for long-term efficacy. Extended access to the inhale r and relapse prevention training could improve success rates. Another promising approach would be to combine the inhaler with a nicotine pa tch.