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Published on: August 6, 2013
Pre-cessation nicotine replacement therapy: pragmatic randomized trial
Chris Bullen1, Colin Howe, Ruey-Bin Lin
1Clinical Trials Research Unit, School of Population Health, The University of Auckland, Auckland, New Zealand. c.bullen@ctru.auckland.ac.nz
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.
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