Trial reportThe European respiratory journal2012
Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial.
Trial report in The European respiratory journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07013084 (Study on the Effect of Digital Smoking Cessation Education Intervention on Outpatients), which is not on this map. Cited by 20 papers, 7 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.
Study on the Effect of Digital Smoking Cessation Education Intervention on Outpatients
Who cites it
20 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Korean Clinical Practice Guideline of Korean Society for Research on Nicotine and Tobacco (KSRNT) and National Evidence-based Healthcare Collaborating Agency (NECA) on Treatment of Tobacco Use 2024.Journal of Korean medical science · 2025Guideline
- The efficacy and acceptability of pharmacological monotherapies and e-cigarette on smoking cessation: a systemic review and network meta-analysis.Frontiers in public health · 2024Pooled it
- Cessation classification likelihood increases with higher expired-air carbon monoxide cutoffs: a meta-analysis.Drug and alcohol dependence · 2021Pooled it
- Smoking cessation interventions for potential use in the lung cancer screening setting: A systematic review and meta-analysis.Lung cancer (Amsterdam, Netherlands) · 2019Pooled it
- Nicotine replacement therapy versus control for smoking cessation.The Cochrane database of systematic reviews · 2018Pooled it
- Diminishing benefit of smoking cessation medications during the first year: a meta-analysis of randomized controlled trials.Addiction (Abingdon, England) · 2018Pooled it
- Pharmacological interventions for smoking cessation: an overview and network meta-analysis.The Cochrane database of systematic reviews · 2013Pooled it
- Effect of nicotine mouth spray on urges to vape: A randomized, placebo-controlled, pharmacodynamic clinical trial in exclusive e-cigarette users.Addiction (Abingdon, England) · 2025Trial
- A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes.Psychopharmacology · 2022Trial
- Article
- Study title: A systematic review of RCTs to examine the risk of adverse cardiovascular events with nicotine use.Frontiers in cardiovascular medicine · 2023Review
- Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review.Journal of multidisciplinary healthcare · 2021Review
- Article
- Modelling continuous abstinence rates over time from clinical trials of pharmacological interventions for smoking cessation.Addiction (Abingdon, England) · 2019Review
- Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice.British journal of clinical pharmacology · 2014Review
- Cardiovascular events associated with smoking cessation pharmacotherapies: a network meta-analysis.Circulation · 2014Article
- Review
- Review
- Smoking cessation and COPD.European respiratory review : an official journal of the European Respiratory Society · 2013Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy, such as a faster uptake of nicotine and faster relief of craving. This multicentre, randomised (2:1), double-blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from week 2 until weeks 6, 24, and 52 in 479 smokers (≥ 1 cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany. Active treatment yielded significantly higher continuous abstinence rates than placebo from week 2 until week 6 (26.1% versus 16.1%; relative success rate (RR) 1.62, 95% CI 1.09-2.41), week 24 (15.7% versus 6.8%; RR 2.30, 95% CI 1.23-4.30), and week 52 (13.8% versus 5.6%; RR 2.48, 95% CI 1.24-4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active spray versus 71.4% with placebo spray. Nicotine mouth spray delivered significantly higher 6-, 24- and 52-week continuous abstinence rates than placebo.
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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.