Authors: Bullen, Chris; Howe, Colin¹; Lin, Ruey-Bin¹; Grigg, Michele²; Laugesen, Murray³; McRobbie, Hayden⁴; Glover, Marewa⁵; Walker, Natalie¹; Wallace-Bell, Mark⁶; Whittaker, Robyn¹; Rodgers, Anthony⁷

Source: Addiction, Volume 105, Number 8, August 2010 , pp. 1474-1483(10)

Publisher: Wiley-Blackwell

Abstract:

Aims 

To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months. Design 

Pragmatic randomized controlled trial. Setting 

New Zealand. Participants 

Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone. Measurements 

The primary outcome was self-reported 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine-verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events. Findings 

Six months after quit day 125 (22.7%) participants in the pre-cessation group and 116 (21.0%) in the control group reported 7-day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: −3.2%, 6.6%). However, when pooled in a meta-analysis with other pre-cessation trials a moderate benefit of about a one-quarter increase in cessation rates was evident. There was no difference in adverse events between groups. Conclusions 

In this, the largest pre-cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre-cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials.

Keywords: Cessation; clinical trial; nicotine replacement therapy; pragmatic; pre-cessation; quit; randomized; smoking

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1360-0443.2010.02989.x

Affiliations: 1: Clinical Trials Research Unit, School of Population Health, The University of Auckland, Auckland, New Zealand, 2: The Quit Group, Wellington, New Zealand, 3: Health New Zealand Ltd, Lyttelton, New Zealand, 4: Queen Mary, University of London, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Turner Street, London, UK, 5: Centre for Tobacco Control Research, Social and Community Health, School of Population Health, The University of Auckland, Auckland, New Zealand, 6: Health Sciences Centre, University of Canterbury, Christchurch, New Zealand and 7: The George Institute for International Health, NSW, Australia

Publication date: 2010-08-01

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