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Cited by 126Smoking Behavior and CessationSubstance Abuse Treatment and OutcomesNicotinic Acetylcholine Receptors Study

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Effectiveness of Extended-Duration Transdermal Nicotine Therapy: A Randomized Trial

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Schnoll, Robert A., Patterson, Freda, Wileyto, E. Paul, Heitjan, Daniel F., Shields, Alexandra E., Asch, David A., Lerman, Caryn·2010·Annals of Internal Medicine
DOI 10.7326/0003-4819-152-3-201002020-00005PMC PMC3782858
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Abstract

BACKGROUND: Tobacco dependence is a chronic, relapsing condition that may require extended treatment. OBJECTIVE: To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers. DESIGN: Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156) SETTING: Academic center. PARTICIPANTS: 568 adult smokers. INTERVENTION: In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks). MEASUREMENTS: The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence. RESULTS: At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment. LIMITATION: The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected. CONCLUSION: Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy. PRIMARY FUNDING SOURCE: National Institutes of Health.

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Research works printed but not linked: 7

  1. Jonk YC, 2005, Am J Manag Care, 11, 77
  2. Tilson L, 2004, Ir Med J, 97, 270
  3. Fiore MC, 2000, Respir Care, 45, 1196
  4. Stead LF, 2008, Cochrane Database Syst Rev, CD000146
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  6. McPhillips-Tangum C, 2004, Prev Chronic Dis, 1, A04
  7. Centers for Disease Control and Prevention (CDC), 2006, MMWR Morb Mortal Wkly Rep, 55, 1194

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Metadata

Authors
Schnoll, R. A., Patterson, F., Wileyto, E. P., Heitjan, D. F., Shields, A. E., Asch, D. A., & Lerman, C.
Affiliations
Massachusetts General Hospital (US)
Corresponding author
Schnoll, Robert A.
ORCID
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2010-02-02
Volume
152
Issue
3
Pages
144-151
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/0003-4819-152-3-201002020-00005
PMC
PMC3782858
OpenAlex
W2016263931
Cited by
126
References
42
Citations by year
2026: 1 · 2025: 4 · 2024: 2 · 2023: 4 · 2022: 5 · 2021: 5 · 2020: 8 · 2019: 8 · 2018: 6 · 2017: 5 · 2016: 9 · 2015: 16 · 2014: 7 · 2013: 13 · 2012: 10
FWCI
9.97
Type
journal article
Language
en
Open access
Licence
www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Cancer Institute (P50CA084718, P50CA/DA-84718, P50CA143187)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › 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
tobacco dependence, smoking cessation, abstinence, relapse, treatment duration, adherence, adverse effects, nicotine withdrawal symptoms
MeSH terms
Administration, Cutaneous, Adult, Double-Blind Method, Female, Humans, Male, Nicotine, Smoking, Time Factors

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