Pre-cessation nicotine replacement therapy: pragmatic randomized trial.
OBJECTIVE
To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months.


METHODS
Pragmatic randomized controlled trial.


METHODS
New Zealand.


METHODS
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.


METHODS
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.


RESULTS
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.
Bullen
Chris
C
Clinical Trials Research Unit, School of Population Health, The University of Auckland, Auckland, New Zealand. c.bullen@ctru.auckland.ac.nz
Howe
Colin
C
Lin
Ruey-Bin
RB
Grigg
Michele
M
Laugesen
Murray
M
McRobbie
Hayden
H
Glover
Marewa
M
Walker
Natalie
N
Wallace-Bell
Mark
M
Whittaker
Robyn
R
Rodgers
Anthony
A
D000279:Administration, Cutaneous; D000328:Adult; D000465:Algorithms; D002638:Chewing Gum; D005260:Female; D015277:Hotlines; D006801:Humans; D008297:Male; D009520:New Zealand; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D010342:Patient Acceptance of Health Care; D012907:Smoking / Q000208:ethnology; D016540:Smoking Cessation / Q000208:ethnology / Q000379:methods* / Q000706:statistics & numerical data; D000074606:Smoking Prevention; D013223:Statistics as Topic; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control; D016896:Treatment Outcome
D002638:Chewing Gum; D018722:Nicotinic Agonists; D009538:Nicotine