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Agneta Hjalmarson, PhD; Fredrik Nilsson, MSc; Lars Sjöström, MD; Olle Wiklund, MD

Arch Intern Med. 1997;157(15):1721-1728.

Abstract
Background
Nicotine replacement therapy has been shown to improve success rates in smoking cessation treatment. However, the available products cause adverse effects, which prevent some smokers from using them. A new method of delivering nicotine via inhaler supplies nicotine orally through inhalation from a plastic tube. This mode of delivering nicotine resembles smoking, as it includes handling and active inhalation.

Objectives
To assess the efficacy and safety of the nicotine inhaler as an aid in smoking cessation.

Methods
A 1-year, randomized, double-blind, placebocontrolled study was conducted in a smoking cessation clinic. Two hundred forty-seven smokers who smoked at least 10 cigarettes per day and who had previously made a serious attempt to stop smoking using nicotine chewing gum were recruited through advertisements. Randomization to treatment or control conditions were made at the first group session, with 123 participants receiving nicotine inhalers and 124 receiving placebo inhalers. The inhalers were distributed at the second session and participants were allowed to use the inhalers for 6 months.

Main Outcome Measure
Biochemically verified continuous abstinence from smoking after 2 and 6 weeks and at 3, 6, and 12 months.

Results
Significantly more participants who had used the nicotine inhalers were continuously abstinent compared with those who had used the placebo inhalers. The respective success rates after 12 months were 28% and 18% (P=.046). At 6 months, 20 participants (16%) in the nicotine group were still using the inhaler, compared with 4 (3%) in the control group (P<.001).

Conclusion
The nicotine inhaler was an effective smoking cessation aid that produced a few mild and transient adverse effects.

Arch Intern Med. 1997;157:1721-1728

Author Affiliations
From the Departments of Heart and Lung Diseases (Drs Hjalmarson and Wiklund) and Medicine (Dr Sjöström), Sahlgrensha University Hospital, Göteborg, and Pharmacia & Upjohn, Helsingborg (Mr Nilsson), Sweden.

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