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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
  5. Hughes JR, 2007, Cochrane Database Syst Rev, CD000031
  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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