Ng. Schneider et al., EFFICACY OF A NICOTINE INHALER IN SMOKING CESSATION - A DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL, Addiction, 91(9), 1996, pp. 1293-1306
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.