title: Combination rapid-acting nicotine mouth spray and nicotine patch therapy in smoking cessation.
abstract: BACKGROUND
  Improved smoking cessation rates are urgently required if New Zealand is to reach its target of a smokefree nation by 2025, during which some 600,000 smokers will need to quit. Nicotine replacement therapy remains a core part of the pharmacological approach to smoking cessation. Oral nicotine solutions with rapid onset have recently become available. We have examined the effect of a nicotine spray and a nicotine patch on smoking cessation for 12 months.
  
  
  METHODS
  We enrolled potential participants-smokers wanting to quit aged 18-70 years, who smoked ≥9 cigarettes per day-with Fagerström Test of Nicotine Dependence score ≥3 in a double-blind trial in 3 trial sites. Smokers were randomized to a nicotine or placebo spray for 6 months, and all received nicotine patches daily for 5 months. They were followed at regular intervals for 12 months.
  
  
  RESULTS
  A total of 1,423 subjects were randomized to nicotine oral spray (1mg of nicotine free base per spray) plus nicotine patch or a placebo spray and nicotine patch. The nicotine mouth spray plus nicotine patch showed significant improvements in prolonged abstinence for all measures to 6 months (7 consecutive days at each visit for 6 months: 15.5% vs. 10.6%; p = .006) for the combination versus placebo and nicotine patch. Thereafter, the differences were not significant.
  
  
  CONCLUSIONS
  The addition of a nicotine mouth spray to a nicotine replacement patch in a population of smokers receiving a low level of behavioral support improved early quitting, but the effects were not sustained.
authors.affiliation: Department of Medicine, University of Otago Wellington, Wellington, New Zealand;
authors.forename: Brent O
authors.initials: BO
authors.lastname: Caldwell
authors.affiliation: National Addiction Centre, University of Otago Christchurch, Christchurch, New Zealand.
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Adamson
authors.affiliation: Department of Medicine, University of Otago Wellington, Wellington, New Zealand; julian.crane@otago.ac.nz.
authors.forename: Julian
authors.initials: J
authors.lastname: Crane
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand / Q000453:epidemiology; D009538:Nicotine / Q000008:administration & dosage*; D012907:Smoking / Q000188:drug therapy* / Q000453:epidemiology; D016540:Smoking Cessation / Q000379:methods*; D013997:Time Factors; D061485:Tobacco Use Cessation Devices / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D009538:Nicotine