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

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Abstract
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 month 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 of exhaled carbon monoxide at each time point compared with 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 (PConclusion: 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.