Trial reportBMJ (Clinical research ed.)2008
Nortriptyline plus nicotine replacement versus placebo plus nicotine replacement for smoking cessation: pragmatic randomised controlled trial.
Trial report in BMJ (Clinical research ed.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 6 syntheses or guidelines pooled it, 56 citations in OpenAlex.
- Antidepressants for smoking cessation.The Cochrane database of systematic reviews · 2020Pooled it
- Antidepressants for smoking cessation.The Cochrane database of systematic reviews · 2014Pooled it
- Past major depression and smoking cessation outcome: a systematic review and meta-analysis update.Addiction (Abingdon, England) · 2013Pooled it
- Weight gain in smokers after quitting cigarettes: meta-analysis.BMJ (Clinical research ed.) · 2012Pooled it
- Efficacy of smoking-cessation interventions for young adults: a meta-analysis.American journal of preventive medicine · 2012Pooled it
- Safety of nortriptyline at equivalent therapeutic doses for smoking cessation: a systematic review and meta-analysis.Drug safety · 2011Pooled it
- Effects on abstinence of nicotine patch treatment before quitting smoking: parallel, two arm, pragmatic randomised trial.BMJ (Clinical research ed.) · 2018Trial
- Lack of attentional retraining effects in cigarette smokers attempting cessation: a proof of concept double-blind randomised controlled trial.Drug and alcohol dependence · 2015Trial
- Trial
- Attentional bias retraining in cigarette smokers attempting smoking cessation (ARTS): study protocol for a double blind randomised controlled trial.BMC public health · 2013Trial
- A randomized controlled trial of a smoking cessation intervention conducted among prisoners.Addiction (Abingdon, England) · 2013Trial
- Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial.BMJ (Clinical research ed.) · 2011Trial
- A pilot randomised controlled trial of the feasibility of using body scan and isometric exercises for reducing urge to smoke in a smoking cessation clinic.BMC public health · 2008Trial
- Antidepressants for smoking cessation.The Cochrane database of systematic reviews · 2023Review
- TOBACCO USE DISORDER AND DUAL DISORDERS Joint statement by the Spanish Psychiatry Society and the Spanish Dual Disorders Society.Actas espanolas de psiquiatria · 2022Article
- Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?BMC medicine · 2018Article
- New Pharmacological Agents to Aid Smoking Cessation and Tobacco Harm Reduction: What Has Been Investigated, and What Is in the Pipeline?CNS drugs · 2016Review
- Health-care interventions to promote and assist tobacco cessation: a review of efficacy, effectiveness and affordability for use in national guideline development.Addiction (Abingdon, England) · 2015Review
- A general method for handling missing binary outcome data in randomized controlled trials.Addiction (Abingdon, England) · 2014Article
- Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice.British journal of clinical pharmacology · 2014Review
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo test the efficacy of nortriptyline plus nicotine replacement therapy compared with placebo plus nicotine replacement therapy for smoking cessation.
designPragmatic randomised controlled trial.
settingNational Health Service stop smoking service clinics.
participants901 people trying to stop smoking.
interventionsParticipants chose their nicotine replacement product, including combinations of nicotine replacement therapy, and received behavioural support. Nortriptyline was started one to two weeks before quit day, with the dose increased from 25 mg to 75 mg daily for eight weeks and reduced if not tolerated.
main outcome measuresPrimary outcome was prolonged confirmed abstinence at six months. Secondary outcomes were prolonged abstinence at 12 months, drug use, severity of side effects, nicotine withdrawal symptoms, and urges to smoke.
results72 of 445 (16%) people using nortriptyline and 55 of 456 (12%) using placebo achieved prolonged abstinence at six months (relative risk 1.34, 95% confidence interval 0.97 to 1.86). At 12 months the corresponding values were 49 (11%) for nortriptyline and 40 (9%) for placebo (1.26, 0.84 to 1.87). 337 (79%) people in the nortriptyline arm and 325 (75%) in the placebo arm were taking combination treatment on quit day, median 75 mg per day in both groups. More people in the nortriptyline arm than in the placebo arm took lower doses. The nortriptyline arm had noticeably higher severity ratings for dry mouth and constipation than the placebo arm, with slightly higher ratings for sweating and feeling shaky. Both groups had similar urges to smoke, but nortriptyline reduced depression and anxiety. Overall, withdrawal symptom scores did not differ.
conclusionsNortriptyline and nicotine replacement therapy are both effective for smoking cessation but the effect of the combination is less than either alone and evidence is lacking that combination treatment is more effective than either alone. Trial registration Current Controlled Trials ISRCTN57852484.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.