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Efficacy of a Nicotine Lozenge for Smoking Cessation
Saul Shiffman, PhD;
Carolyn M. Dresler, MD;
Peter Hajek, PhD;
Simon J. A. Gilburt, PhD;
Darren A. Targett, MSc;
Kenneth R. Strahs, PhD
Arch Intern Med. 2002;162:1267-1276.
Background Since nicotine gum was introduced in the 1980s, nicotine replacement
therapy has become the most widely used pharmacological smoking cessation
treatment. Some smokers prefer acute oral forms, but many smokers reject chewing
gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge
for smoking cessation.
Methods Double-blind, placebo-controlled, randomized clinical trial with parallel
arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned
to a lozenge dose on the basis of nicotine dependence, assessed by time to
the first cigarette of the day. Low-dependence smokers were randomized to
receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence
smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed
abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal
symptoms.
Results Treatment with the nicotine lozenge resulted in significantly greater
28-day abstinence at 6 weeks, for the 2-mg (46.0% vs 29.7%; odds ratio [OR],
2.10; 95% confidence interval [CI], 1.59-2.79; P<.001)
and the 4-mg (48.7% vs 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects
were maintained for a full year. Smokers who used more lozenges achieved significantly
better treatment effects. Use of the active lozenge also resulted in reduced
craving and withdrawal. Most adverse events were moderate and resembled those
seen with nicotine gum.
Conclusion The nicotine lozenge is a safe and effective new treatment for smoking
cessation in low- and high-dependence smokers.
From Pinney Associates and the Departments of Psychology, Psychiatry,
and Pharmaceutical Science, University of Pittsburgh, Pittsburgh, Pa (Dr Shiffman);
GlaxoSmithKline Consumer Healthcare, Parsippany, NJ (Drs Dresler and Strahs),
and Weybridge, England (Dr Gilburt and Mr Targett); and the Department of
Psychology, University of London, London, England (Dr Hajek). Dr Shiffman
provides consulting to GlaxoSmithKline Healthcare on matters relating to smoking
control, and was compensated for his work on this project. Dr Shiffman also
has an interest in a novel nicotine replacement product that is not addressed
by this article. Dr Hajek has provided consulting to and received research
funding from pharmaceutical companies, including GlaxoSmithKline Consumer
Healthcare and Pharmacia Consumer Healthcare, Peapack, NJ. Drs Dresler, Gilburt,
and Strahs and Mr Targett are employed by GlaxoSmithKline Consumer Healthcare.
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