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Cited by 1,361Smoking Behavior and CessationNicotinic Acetylcholine Receptors StudySubstance Abuse Treatment and Outcomes

The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.

Varenicline, an α4β2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for Smoking Cessation<SUBTITLE>A Randomized Controlled Trial</SUBTITLE>

Gonzales, David·2006·JAMA
DOI 10.1001/jama.296.1.47
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Abstract

CONTEXT: The alpha4beta2 nicotinic acetylcholine receptors (nAChRs) are linked to the reinforcing effects of nicotine and maintaining smoking behavior. Varenicline, a novel alpha4beta2 nAChR partial agonist, may be beneficial for smoking cessation. OBJECTIVE: To assess efficacy and safety of varenicline for smoking cessation compared with sustained-release bupropion (bupropion SR) and placebo. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, parallel-group, placebo- and active-treatment-controlled, phase 3 clinical trial conducted at 19 US centers from June 19, 2003, to April 22, 2005. Participants were 1025 generally healthy smokers (> or =10 cigarettes/d) with fewer than 3 months of smoking abstinence in the past year, 18 to 75 years old, recruited via advertising. INTERVENTION: Participants were randomly assigned in a 1:1:1 ratio to receive brief counseling and varenicline titrated to 1 mg twice per day (n = 352), bupropion SR titrated to 150 mg twice per day (n = 329), or placebo (n = 344) orally for 12 weeks, with 40 weeks of nondrug follow-up. MAIN OUTCOME MEASURES: Primary outcome was the exhaled carbon monoxide-confirmed 4-week rate of continuous abstinence from smoking for weeks 9 through 12. A secondary outcome was the continuous abstinence rate for weeks 9 through 24 and weeks 9 through 52. RESULTS: For weeks 9 through 12, the 4-week continuous abstinence rates were 44.0% for varenicline vs 17.7% for placebo (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.70-5.50; P<.001) and vs 29.5% for bupropion SR (OR, 1.93; 95% CI, 1.40-2.68; P<.001). Bupropion SR was also significantly more efficacious than placebo (OR, 2.00; 95% CI, 1.38-2.89; P<.001). For weeks 9 through 52, the continuous abstinence rates were 21.9% for varenicline vs 8.4% for placebo (OR, 3.09; 95% CI, 1.95-4.91; P<.001) and vs 16.1% for bupropion SR (OR, 1.46; 95% CI, 0.99-2.17; P = .057). Varenicline reduced craving and withdrawal and, for those who smoked while receiving study drug, smoking satisfaction. No sex differences in efficacy for varenicline were observed. Varenicline was safe and generally well tolerated, with study drug discontinuation rates similar to those for placebo. The most common adverse events for participants receiving active-drug treatment were nausea (98 participants receiving varenicline [28.1%]) and insomnia (72 receiving bupropion SR [21.9%]). CONCLUSION: Varenicline was significantly more efficacious than placebo for smoking cessation at all time points and significantly more efficacious than bupropion SR at the end of 12 weeks of drug treatment and at 24 weeks. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00141206.

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Metadata

Authors
Gonzales, D.
Affiliations
Oregon Health & Science University (US)
Corresponding author
Gonzales, David
ORCID
Gonzales, David
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2006-07-05
Volume
296
Issue
1
Pages
47
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.296.1.47
OpenAlex
W2107200746
Cited by
1,361
References
29
Citations by year
2026: 32 · 2025: 21 · 2024: 25 · 2023: 25 · 2022: 34 · 2021: 26 · 2020: 52 · 2019: 49 · 2018: 41 · 2017: 51 · 2016: 50 · 2015: 70 · 2014: 74 · 2013: 80 · 2012: 94
FWCI
85.72
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Oregon Health and Science University
  • Cardinal Health
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, bupropion sustained release, smoking cessation, α4β2 nicotinic acetylcholine receptor, partial agonists, nicotine dependence, continuous abstinence, exhaled carbon monoxide, brief counseling, nicotine replacement therapy, drug safety, adverse events, relapse, nicotine withdrawal symptoms, nicotine self-administration
MeSH terms
Varenicline, Adult, Benzazepines, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Middle Aged, Quinoxalines, Receptors, Nicotinic, Smoking Cessation, Bupropion, Nicotinic Agonists, Dopamine Uptake Inhibitors

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