Cited by 380Smoking Behavior and CessationNicotinic Acetylcholine Receptors StudySubstance Abuse Treatment and Outcomes

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Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation

Oncken, Cheryl·2006·Archives of Internal Medicine

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Abstract

BACKGROUND: The selective nicotinic acetylcholine receptor partial agonist, varenicline tartrate, represents a novel type of therapy for smoking cessation. This study evaluated the efficacy, safety, and tolerability of 4 varenicline dose regimens, 2 with progressive dosing over the first week (eg, titrated) and 2 with a fixed dosing schedule (eg, non-titrated), for promoting smoking cessation. METHODS: This multicenter, double-blind, placebo-controlled study randomized healthy smokers (aged 18-65 years) to varenicline tartrate, 0.5 mg twice daily nontitrated (n = 129), 0.5 mg twice daily titrated (n = 130), 1.0 mg twice daily nontitrated (n = 129), 1.0 mg twice daily titrated (n = 130), or placebo (n = 129) for 12 weeks to aid in smoking cessation. A 40-week follow-up period assessed long-term efficacy. The primary efficacy measures were the carbon monoxide-confirmed 4-week continuous quit rates by pooled dosage group for weeks 4 through 7 and 9 through 12 and the continuous abstinence rates for weeks 9 through 52. RESULTS: Weeks 9 through 12 continuous quit rates were greater in the 1.0-mg group (49.4%) and the 0.5-mg group (44.0%) vs placebo (11.6%; P<.001 vs both doses). Weeks 9 through 52 abstinence rates were greater in the 1.0-mg group (22.4%; P<.001) and the 0.5-mg group (18.5%; P<.001) vs placebo (3.9%). Varenicline was generally well tolerated, with nausea occurring in 16% to 42% of varenicline-treated subjects. Reports of nausea were lower for the titrated vs nontitrated dosing and infrequently led to medication discontinuation. CONCLUSION: Varenicline tartrate, 0.5 mg and 1.0 mg twice daily, is efficacious for smoking cessation.

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Authors: Oncken, C.
Affiliations: UConn Health (US)
Corresponding author: Oncken, Cheryl
ORCID: Oncken, Cheryl
Venue: Archives of Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2006-08-14
Volume: 166
Issue: 15
Pages: 1571
ISSN: 0003-9926 (ISSN-L)
DOI: 10.1001/archinte.166.15.1571
OpenAlex: W2113308458
Cited by: 380
References: 14
Citations by year: 2026: 2 · 2025: 5 · 2024: 7 · 2023: 8 · 2022: 4 · 2021: 9 · 2020: 13 · 2019: 7 · 2018: 13 · 2017: 9 · 2016: 15 · 2015: 28 · 2014: 23 · 2013: 17 · 2012: 28
FWCI: 26.09
Type: journal article
Language: en
Open access: closed
Locations: Archives of Internal Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Keywords: varenicline, smoking cessation, dose titration, abstinence rates, nausea, drug safety, nicotine dependence
MeSH terms: Varenicline, Adolescent, Adult, Aged, Benzazepines, Double-Blind Method, Female, Humans, Male, Middle Aged, Quinoxalines, Tobacco Use Disorder, Smoking Cessation, Treatment Outcome, Nicotinic Agonists, Nicotinic Antagonists

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Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation

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