Smoking reduction with oral nicotine inhalers: Double blind, randomised clinical trial of efficacy and safety

Objectives. To determine whether use of an oral nicotine inhaler can result in long term reduction in smoking and whether concomitant use of nicotine replacement and smoking is safe. Design. Double blind, randomised, placebo controlled trial. Four months trial with a two year follow up. Setting. Two university hospital pulmonary clinics in Switzerland. Participants. 400 healthy volunteers, recruited through newspaper advertisements, willing to reduce their smoking but unable or unwilling to stop smoking immediately. Intervention. Active or placebo inhaler as needed for up to 18 months, with participants encouraged to limit their smoking as much as possible. Main outcome measures. Number of cigarettes smoked per day from week six to end point. Decrease verified by a measurement at baseline. Results. At four months sustained reduction of smoking was achieved in 52 (26%) participants in the active group and 18 (9%) in the placebo group (P < 0.001; Fisher's test). Corresponding figures after two years were 19 (9.5%) and 6 (3.0%) (P = 0.012). Conclusions. Nicotine inhalers effectively and safely achieved sustained reduction in smoking over 24 months. Reduction with or without nicotine substitution may be a feasible first step towards smoking cessation in people not able or not willing to stop abruptly.