Cited by 265Smoking Behavior and CessationSubstance Abuse Treatment and OutcomesNicotinic Acetylcholine Receptors Study

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Efficacy of a Nicotine Lozenge for Smoking Cessation

Shiffman, Saul, Dresler, Carolyn M., Hajek, Peter, Gilburt, Simon J. A., Targett, Darren A., Strahs, Kenneth R.·2002·Archives of Internal Medicine

DOI 10.1001/archinte.162.11.1267

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Abstract

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.

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Authors: Shiffman, S., Dresler, C. M., Hajek, P., Gilburt, S. J. A., Targett, D. A., & Strahs, K. R.
Affiliations: Pinney Associates (United States) (US)
ORCID: Shiffman, Saul
Venue: Archives of Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2002-06-10
Volume: 162
Issue: 11
Pages: 1267
ISSN: 0003-9926 (ISSN-L)
DOI: 10.1001/archinte.162.11.1267
OpenAlex: W2132992773
Cited by: 265
References: 34
Citations by year: 2025: 6 · 2024: 2 · 2023: 3 · 2022: 5 · 2021: 8 · 2020: 8 · 2019: 4 · 2018: 3 · 2017: 8 · 2016: 7 · 2015: 5 · 2014: 9 · 2013: 10 · 2012: 13
FWCI: 11.02
Type: journal article
Language: en
Open access: closed
Locations: Archives of Internal Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: GlaxoSmithKline
University of Pittsburgh
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
Keywords: nicotine lozenges, smoking cessation, nicotine replacement therapy, nicotine dependence, abstinence, craving, withdrawal symptoms, nicotine gum, adverse events
MeSH terms: Adult, Double-Blind Method, Female, Humans, Male, Middle Aged, Nicotine, Polymethacrylic Acids, Polyvinyls, Tablets, Smoking Cessation, Tobacco Use Cessation Devices

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Efficacy of a Nicotine Lozenge for Smoking Cessation

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