title: Cytisine versus nicotine for smoking cessation.
abstract: BACKGROUND
  Placebo-controlled trials indicate that cytisine, a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation, almost doubles the chances of quitting at 6 months. We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit.
  
  
  METHODS
  We conducted a pragmatic, open-label, noninferiority trial in New Zealand in which 1310 adult daily smokers who were motivated to quit and called the national quitline were randomly assigned in a 1:1 ratio to receive cytisine for 25 days or nicotine-replacement therapy for 8 weeks. Cytisine was provided by mail, free of charge, and nicotine-replacement therapy was provided through vouchers for low-cost patches along with gum or lozenges. Low-intensity, telephone-delivered behavioral support was provided to both groups through the quitline. The primary outcome was self-reported continuous abstinence at 1 month.
  
  
  RESULTS
  At 1 month, continuous abstinence from smoking was reported for 40% of participants receiving cytisine (264 of 655) and 31% of participants receiving nicotine-replacement therapy (203 of 655), for a difference of 9.3 percentage points (95% confidence interval, 4.2 to 14.5). The effectiveness of cytisine for continuous abstinence was superior to that of nicotine-replacement therapy at 1 week, 2 months, and 6 months. In a prespecified subgroup analysis of the primary outcome, cytisine was superior to nicotine-replacement therapy among women and noninferior among men. Self-reported adverse events over 6 months occurred more frequently in the cytisine group (288 events among 204 participants) than in the group receiving nicotine-replacement therapy (174 events among 134 participants); adverse events were primarily nausea and vomiting and sleep disorders.
  
  
  CONCLUSIONS
  When combined with brief behavioral support, cytisine was found to be superior to nicotine-replacement therapy in helping smokers quit smoking, but it was associated with a higher frequency of self-reported adverse events. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12610000590066.).
authors.affiliation: From the National Institute for Health Innovation (N.W., C.H., V.P., C.B.), the Centre for Tobacco Control Research, Department of Social and Community Health (M.G.), the Department of Pacific Health (V.N.) and the School of Population Health and the School of Pharmacy (J.B.), University of Auckland, Auckland, and the Quit Group, Wellington (B.B.) - all in New Zealand; and Queen Mary University of London, Wolfson Institute of Preventive Medicine, and UK Centre for Tobacco and Alcohol Studies, Barts and the London School of Medicine and Dentistry - all in London (H.M.).
authors.forename: Natalie
authors.initials: N
authors.lastname: Walker
authors.forename: Colin
authors.initials: C
authors.lastname: Howe
authors.forename: Marewa
authors.initials: M
authors.lastname: Glover
authors.forename: Hayden
authors.initials: H
authors.lastname: McRobbie
authors.forename: Joanne
authors.initials: J
authors.lastname: Barnes
authors.forename: Vili
authors.initials: V
authors.lastname: Nosa
authors.forename: Varsha
authors.initials: V
authors.lastname: Parag
authors.forename: Bruce
authors.initials: B
authors.lastname: Bassett
authors.forename: Christopher
authors.initials: C
authors.lastname: Bullen
mesh_terms: D000328:Adult; D000470:Alkaloids / Q000009:adverse effects / Q000627:therapeutic use*; D001392:Azocines / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009538:Nicotine / Q000009:adverse effects / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D011807:Quinolizines / Q000009:adverse effects / Q000627:therapeutic use; D016540:Smoking Cessation / Q000379:methods*; D061485:Tobacco Use Cessation Devices; D014029:Tobacco Use Disorder / Q000188:drug therapy*; D016896:Treatment Outcome; D000093843:Quinolizidine Alkaloids
chemical_list: D000470:Alkaloids; D001392:Azocines; D009538:Nicotine; D011807:Quinolizines; C004712:cytisine; D000093843:Quinolizidine Alkaloids