title: Long-term nicotine replacement therapy: a randomized clinical trial.
abstract: OBJECTIVE
  The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard 8 weeks. This decision was based in part on data showing increased efficacy for 24 weeks of treatment. Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit.
  
  
  OBJECTIVE
  To compare 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.
  
  
  METHODS
  We recruited 525 treatment-seeking smokers for a randomized clinical trial conducted from June 22, 2009, through April 15, 2014, through 2 universities.
  
  
  METHODS
  Smokers received 12 smoking cessation behavioral counseling sessions and were randomized to 8, 24, or 52 weeks of nicotine patch treatment.
  
  
  METHODS
  The primary outcome was 7-day point prevalence abstinence, confirmed with breath levels of carbon monoxide at 6 and 12 months (intention to treat).
  
  
  RESULTS
  At 24 weeks, 21.7% of participants in the standard treatment arm were abstinent, compared with 27.2% of participants in the extended and maintenance treatment arms (χ(2)(1) = 1.98; P = .17). In a multivariate model controlled for covariates, participants in the extended and maintenance treatment arms reported significantly greater abstinence rates at 24 weeks compared with participants in the standard treatment arm (odds ratio [OR], 1.70 [95% CI, 1.03-2.81]; P = .04), had a longer duration of abstinence until relapse (β = 21.30 [95% CI, 10.30-32.25]; P < .001), reported smoking fewer cigarettes per day if not abstinent (mean [SD], 5.8 [5.3] vs 6.4 [5.1] cigarettes per day; β = 0.43 [95% CI, 0.06-0.82]; P = .02), and reported more abstinent days (mean [SD], 80.5 [38.1] vs 68.2 [43.7] days; OR, 1.55 [95% CI, 1.06-2.26]; P = .02). At 52 weeks, participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms (20.3% vs 23.8%; OR, 1.17 [95% CI, 0.69-1.98]; P = .57). Similarly, we found no difference in week 52 abstinence rates between participants in the extended and standard treatment arms (26.0% vs 21.7%; OR, 1.33 [95% CI, 0.72-2.45]; P = .36). Treatment duration was not associated with any adverse effects or adherence to the counseling regimen, but participants in the maintenance treatment arm reported lower adherence to the nicotine patch regimen compared with those in the standard and extended treatment arms (mean [SD], 3.94 [2.5], 4.61 [2.0], and 4.7 [2.4] patches/wk, respectively; F2,522 = 6.03; P = .003).
  
  
  CONCLUSIONS
  The findings support the safety of long-term use of nicotine patch treatment, although they do not support efficacy beyond 24 weeks of treatment in a broad group of smokers.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01047527.
authors.affiliation: Department of Psychiatry, University of Pennsylvania, Philadelphia.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Schnoll
authors.affiliation: National Comprehensive Cancer Network, Ft Washington, Pennsylvania.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Goelz
authors.affiliation: Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Anna
authors.initials: A
authors.lastname: Veluz-Wilkins
authors.affiliation: Department of Psychiatry, University of Pennsylvania, Philadelphia.
authors.forename: Sonja
authors.initials: S
authors.lastname: Blazekovic
authors.affiliation: Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Powers
authors.affiliation: Pulmonary, Allergy, and Critical Care Division, University of Pennsylvania Presbyterian Medical Center, Philadelphia.
authors.forename: Frank T
authors.initials: FT
authors.lastname: Leone
authors.affiliation: Department of Psychiatry, University of Pennsylvania, Philadelphia.
authors.forename: Peter
authors.initials: P
authors.lastname: Gariti
authors.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia.
authors.forename: E Paul
authors.initials: EP
authors.lastname: Wileyto
authors.affiliation: Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Brian
authors.initials: B
authors.lastname: Hitsman
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D037001:Directive Counseling; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D012008:Recurrence; D057566:Self Report; D012907:Smoking / Q000628:therapy; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D061485:Tobacco Use Cessation Devices / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D009538:Nicotine