Double blind trial of repeated treatment with transdermal nicotine for relapsed smokers

BMJ 1995;311:363-366 (5 August)

General practice

Double blind trial of repeated treatment with transdermal nicotine for relapsed smokers

Steven G Gourlay, National Health and Medical Research Council of Australia public health research fellow,^a Andrew Forbes, senior lecturer,^a Tracey Marriner, research coordinator,^a Damian Pethica, medical director,^b John J McNeil, professor and chairman ^a

^a Department of Social and Preventive Medicine, Monash University, Melbourne, Australia 3168, ^b Ciba-Geigy New Zealand, Auckland, New Zealand

Correspondence to: Dr Gourlay.

Abstract

Objective: To assess the efficacy and safety of a repeat courseof treatment with transdermal nicotine for cessation of smokingin a brief intervention setting.
Study design: Randomised, double blind, placebo controlled trialwith follow up for 26 weeks.
Subjects: 629 smokers who had unsuccessfully attempted to stopsmoking by using active transdermal nicotine and brief behaviouralcounselling. Smokers were motivated to quit smoking for a secondtime and smoked >/=15 cigarettes a day.
Interventions: Twelve weeks' treatment with active transdermalnicotine patches or placebo and brief counselling at monthlyvisits.
Main outcome measure: Sustained smoking cessation for the 28days before the visit at week 12 verified by expired carbonmonoxide concentrations.
Results: At 12 weeks 21/315 (6.7%) subjects allocated to activetreatment had stopped smoking compared with 6/314 (1.9%) allocatedto placebo (absolute difference 4.7%; 95% confidence interval1.6% to 7.9%; P=0.003). At 26 weeks the rates were 20/315 (6.4%)and 8/314 (2.6%) (3.8%; 0.6% to 7.0%; P=0.021). Difficulty insleeping was reported by 43/179 (24.0%) on active treatmentand 19/143 (13.3%) on placebo (P=0.015). Severe reactions atthe site of application were rare (6/322; 1.9%).
Conclusions: Repeated treatment with transdermal nicotine togetherwith brief counselling can improve the low success rates ofsmoking cessation in recently relapsed, moderate to heavy smokers.Questions remain about whether more intensive interventionsor higher doses of nicotine could be more effective. The likelihoodof severe reactions at the site of application with repeatedtreatment is low.

Key messages

Key messages
Transdermal nicotine can improve quit rates when used for a second time in a brief intervention setting
Questions remain about whether more intensive support programmes or higher doses of nicotine could be more effective for relapsed, moderate to heavy smokers
The likelihood of severe reactions at the site of application with repeated use of transdermal nicotine is low

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