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Cited by 661Smoking Behavior and CessationSubstance Abuse Treatment and OutcomesNicotinic Acetylcholine Receptors Study

Effect of Maintenance Therapy With Varenicline on Smoking Cessation<SUBTITLE>A Randomized Controlled Trial</SUBTITLE>

Tonstad, Serena·2006·JAMA
DOI 10.1001/jama.296.1.64
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Abstract

CONTEXT: The majority of cigarette smokers who achieve abstinence relapse within the first year and require many attempts before achieving permanent abstinence. Evidence to support pharmacological treatment for relapse prevention is insufficient. OBJECTIVE: To determine whether smokers who quit after 12 weeks of treatment with varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, maintain greater continuous abstinence rates (defined as not a single "puff" of a cigarette) than placebo controls during an additional 12 weeks of treatment and until 52 weeks after treatment initiation. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted at multiple medical clinics in 7 countries with follow-up to 52 weeks after study baseline. Of 1927 cigarette smokers recruited between April 2003 and February 2004 and treated for 12 weeks with open-label varenicline titrated to 1 mg twice per day, 1236 (64.1%) did not smoke, use tobacco, or use nicotine replacement therapy during the last week of treatment and 62.8% (n = 1210) were randomized to additional treatment or placebo. INTERVENTION: Participants were randomly assigned to receive either double-blind varenicline, 1 mg twice per day (n = 603), or placebo (n = 607) for an additional 12 weeks. MAIN OUTCOME MEASURES: Carbon monoxide-confirmed continued abstinence during weeks 13 to 24 and weeks 13 to 52 of the study. RESULTS: The carbon monoxide-confirmed continuous abstinence rate was significantly higher for the varenicline group than for the placebo group for weeks 13 to 24 (70.5% vs 49.6%; odds ratio [OR], 2.48; 95% confidence interval [CI], 1.95-3.16; P<.001) as well as for weeks 13 to 52 (43.6% vs 36.9%; OR, 1.34; 95% CI, 1.06-1.69; P = .02). Adverse events reported in the open-label period were mostly mild; no difference in adverse events between varenicline and placebo was observed during the double-blind period. CONCLUSIONS: Smokers who achieved abstinence for at least 7 days at the end of 12 weeks of open-label varenicline treatment and were randomized to receive an additional 12 weeks of varenicline treatment showed significantly greater continuous abstinence in weeks 13 to 24 compared with placebo. This advantage was maintained through the nontreatment follow-up to week 52. Varenicline may be an efficacious, safe, and well-tolerated agent for maintaining abstinence from smoking. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00143286.

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Crossref · 10.1001/jama.296.1.64

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  • More than 50% of test subjects relapsed at 1 year post quit irrespective of the treatment group.

    “450% of the test subjects relapsed at 1 year post quit irrespective of the treatment group (Tonstad et al, 2006).”

    From Divergent Functional Effects of Sazetidine-A and Varenicline During Nicotine Withdrawal (2013) · cites this paper as Tonstad et al, 2006

  • Varenicline has shown some efficacy as a relapse prevention agent; continuous abstinence rates from weeks 13 to 24 and 13 to 52 were significantly higher for varenicline compared to placebo, but the effect was relatively modest (OR at 52 weeks 1.3, 95% CI 1.1 to 1.7).

    “The continuous abstinence rates from weeks 13 to 24 and weeks 13 to 52 were significantly higher for varenicline compared to placebo but the effect was relatively modest (OR at 52 weeks 1.3; 95% CI 1.1, 1.7)”

    From Tobacco addiction (2008) · cites this paper as [119]

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Authors
Tonstad, S.
Affiliations
University of Oslo (NO)
Corresponding author
Tonstad, Serena
ORCID
Tonstad, Serena
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2006-07-05
Volume
296
Issue
1
Pages
64
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.296.1.64
OpenAlex
W2053457282
Cited by
660
References
23
Citations by year
2026: 5 · 2025: 6 · 2024: 12 · 2023: 12 · 2022: 11 · 2021: 13 · 2020: 31 · 2019: 14 · 2018: 20 · 2017: 15 · 2016: 23 · 2015: 34 · 2014: 24 · 2013: 35 · 2012: 47
FWCI
54.35
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Cardinal Health
  • Universitetet i Oslo
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
varenicline, smoking cessation, relapse prevention, maintenance therapy, continuous abstinence, nicotine dependence, α4β2 nicotinic acetylcholine receptor, long-term follow-up, adverse events, nicotine replacement therapy, smoking cessation clinics, smoking cessation services
MeSH terms
Varenicline, Adult, Benzazepines, Double-Blind Method, Female, Humans, Male, Middle Aged, Quinoxalines, Receptors, Nicotinic, Smoking Cessation, Nicotinic Agonists

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