Nortriptyline plus nicotine replacement versus placebo plus nicotine replacement for smoking cessation: pragmatic randomised controlled trial

doi:10.1136/bmj.39545.852616.BE

BMJ 2008;336:1223-1227 (31 May), doi:10.1136/bmj.39545.852616.BE (published 27 April 2008)

Research

Nortriptyline plus nicotine replacement versus placebo plus nicotine replacement for smoking cessation: pragmatic randomised controlled trial

Paul Aveyard, National Institute for Health Research career scientist¹, Carol Johnson, lecturer², Sally Fillingham, research associate¹, Amanda Parsons, research associate¹, Mike Murphy, consultant epidemiologist³

¹ Division of Primary Care and Public Health, University of Birmingham, Birmingham B15 2TT, ² School of Health Sciences, University of Birmingham, ³ Childhood Cancer Research Group, University of Oxford

Correspondence to: P Aveyard p.n.aveyard{at}bham.ac.uk

Objective To test the efficacy of nortriptyline plus nicotinereplacement therapy compared with placebo plus nicotine replacementtherapy for smoking cessation.

Design Pragmatic randomised controlled trial.

Setting National Health Service stop smoking service clinics.

Participants 901 people trying to stop smoking.

Interventions Participants chose their nicotine replacementproduct, including combinations of nicotine replacement therapy,and received behavioural support. Nortriptyline was startedone to two weeks before quit day, with the dose increased from25 mg to 75 mg daily for eight weeks and reduced if not tolerated.

Main outcome measures Primary outcome was prolonged confirmedabstinence at six months. Secondary outcomes were prolongedabstinence at 12 months, drug use, severity of side effects,nicotine withdrawal symptoms, and urges to smoke.

Results 72 of 445 (16%) people using nortriptyline and 55 of456 (12%) using placebo achieved prolonged abstinence at sixmonths (relative risk 1.34, 95% confidence interval 0.97 to1.86). At 12 months the corresponding values were 49 (11%) fornortriptyline and 40 (9%) for placebo (1.26, 0.84 to 1.87).337 (79%) people in the nortriptyline arm and 325 (75%) in theplacebo arm were taking combination treatment on quit day, median75 mg per day in both groups. More people in the nortriptylinearm than in the placebo arm took lower doses. The nortriptylinearm had noticeably higher severity ratings for dry mouth andconstipation than the placebo arm, with slightly higher ratingsfor sweating and feeling shaky. Both groups had similar urgesto smoke, but nortriptyline reduced depression and anxiety.Overall, withdrawal symptom scores did not differ.

Conclusions Nortriptyline and nicotine replacement therapy areboth effective for smoking cessation but the effect of the combinationis less than either alone and evidence is lacking that combinationtreatment is more effective than either alone.

Trial registration Current Controlled Trials ISRCTN57852484 [controlled-trials.com] .

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Smoking cessation in primary care: Sean P David and Marcus R Munafò
BMJ 2008 336: 1200-1201. [Extract] [Full Text] [PDF]

Understanding controlled trials: What are pragmatic trials?: Martin Roland and David J Torgerson
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This article has been cited by other articles:

David, S. P, Munafo, M. R (2008). Smoking cessation in primary care. BMJ 336: 1200-1201 [Full text]

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Correction: Paul Aveyard
bmj.com, 30 Apr 2008 [Full text]
Nortriptyline for smoking prevention: what are the doses?: Om Prakash
bmj.com, 1 May 2008 [Full text]