title: The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial.
abstract: OBJECTIVE
  To determine the combined effect of very low nicotine content (VLNC) cigarettes and usual Quitline care [nicotine replacement therapy (NRT) and behavioural support] on smoking abstinence, in smokers motivated to quit.
  
  
  METHODS
  Single-blind, parallel randomized trial.
  
  
  METHODS
  New Zealand. PARTICIPANTS Smokers who called the Quitline for quitting support were randomized to either VLNC cigarettes to use whenever they had an urge to smoke for up to 6 weeks after their quit date, in combination with usual Quitline care (8 weeks of NRT patches and/or gum or lozenges, plus behavioural support) or to usual Quitline care alone.
  
  
  METHODS
  The primary outcome was 7-day point-prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, self-efficacy, alcohol use, serious adverse events and views on the use of the VLNC cigarettes at 3 and 6 weeks and 3 and 6 months.
  
  
  RESULTS
  A total of 1410 participants were randomized (705 in each arm), with a 24% loss to follow-up at 6 months. Participants in the intervention group were more likely to have quit smoking at 6 months compared to the usual care group [7-day point-prevalence abstinence 33 versus 28%, relative risk (RR) = 1.18, 95% confidence interval (CI): 1.01, 1.39, P = 0.037; continuous abstinence 23 versus 15%, RR = 1.50, 95% CI: 1.20, 1.87, P = 0.0003]. The median time to relapse in the intervention group was 2 months compared to 2 weeks in the usual care group (P < 0.0001).
  
  
  CONCLUSIONS
  Addition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent.
authors.affiliation: Clinical Trials Research Unit, School of Population Health, The University of Auckland, Auckland, New Zealand. n.walker@ctru.auckland.ac.nz
authors.forename: Natalie
authors.initials: N
authors.lastname: Walker
authors.forename: Colin
authors.initials: C
authors.lastname: Howe
authors.forename: Chris
authors.initials: C
authors.lastname: Bullen
authors.forename: Michele
authors.initials: M
authors.lastname: Grigg
authors.forename: Marewa
authors.initials: M
authors.lastname: Glover
authors.forename: Hayden
authors.initials: H
authors.lastname: McRobbie
authors.forename: Murray
authors.initials: M
authors.lastname: Laugesen
authors.forename: Varsha
authors.initials: V
authors.lastname: Parag
authors.forename: Robyn
authors.initials: R
authors.lastname: Whittaker
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009538:Nicotine / Q000008:administration & dosage* / Q000032:analysis; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000032:analysis; D012008:Recurrence; D016037:Single-Blind Method; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data; D062789:Tobacco Products / Q000032:analysis*; D061485:Tobacco Use Cessation Devices; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine