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

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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  • Medically approved oral smoking cessation aids such as nicotine gum and nicotine lozenges with a higher nicotine content and which give greater nicotine delivery to users have previously been shown to be more effective in assisting smoking cessation than products with a lower nicotine content, particularly in more heavily dependent smokers.

    “medically approved oral smoking cessation aids such as nicotine gum and nicotine lozenges with a higher nicotine content and which give greater nicotine delivery to users [36] have previously been shown to be more effective in assisting smoking cessation than products with a lower nicotine content, particularly in more heavily dependent smokers [37–40].”

    From A Randomised Study to Investigate the Nicotine Pharmacokinetics of Oral Nicotine Pouches and a Combustible Cigarette (2022) · cites this paper as [40]

  • Smokers who used NRT with no behavioral support doubled their odds of 6 months abstinence compared to nonusers, adjusting for nicotine dependence, with a difference in success rates of approximately 4%.

    “In this study smokers who used NRT with no behavioral support doubled their odds of 6 months abstinence compared to non users, adjusting for nicotine dependence, with a difference in success rates of approximately 4%.”

    From Tobacco addiction (2008) · cites this paper as [95]

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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 › Physiology › 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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