Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation
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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Clinical efficacy trials show that varenicline reduces smoking reward during a lapse.
“These trials document treatment-related reductions in smoking urges and withdrawal-related negative affect (4, 5, 9), as well as reduced smoking reward during a lapse (10).”
From Varenicline improves mood and cognition during smoking abstinence (2009) · cites this paper as [10]
In a recent trial, 7-day point prevalence abstinence at week 52 was 37% for varenicline vs 8% for placebo.
“The 7-day point prevalence was 37% vs. 8%, respectively at week 52 (108).”
From Tobacco addiction (2008) · cites this paper as [108]
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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)
- 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 › Physiology › 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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