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Randomized Controlled Trial
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.
- Natalie Walker, Colin Howe, Chris Bullen, Michele Grigg, Marewa Glover, Hayden McRobbie, Murray Laugesen, Varsha Parag, and Robyn Whittaker.
- Clinical Trials Research Unit, School of Population Health, The University of Auckland, Auckland, New Zealand. n.walker@ctru.auckland.ac.nz
- Addiction. 2012 Oct 1;107(10):1857-67.
AimTo 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.DesignSingle-blind, parallel randomized trial.SettingNew 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.MeasurementsThe 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.FindingsA 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).ConclusionsAddition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent.© 2012 Auckland Uni Services Ltd.
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