Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2009
A randomized clinical trial of nicotine lozenge for smokeless tobacco use.
Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 5 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
17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Interventions for smokeless tobacco use cessation.The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy of pharmacological intervention for smokeless tobacco cessation in adults: a systematic review and meta-analysis.Archives of public health = Archives belges de sante publique · 2025Pooled it
- Smokeless tobacco cessation interventions: A systematic review.The Indian journal of medical research · 2018Pooled it
- Nicotine replacement therapy versus control for smoking cessation.The Cochrane database of systematic reviews · 2018Pooled it
- Interventions for smokeless tobacco use cessation.The Cochrane database of systematic reviews · 2015Pooled it
- Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2015Trial
- A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014Trial
- A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2013Trial
- Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012Trial
- A pilot study of the efficacy of varenicline for the treatment of smokeless tobacco users in Midwestern United States.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2011Trial
- Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial.BMJ (Clinical research ed.) · 2010Trial
- Comparative Evaluation of the Effect of Pharmacotherapy, Low-Level Laser Therapy, and Behavioral Counseling on Tobacco Cessation: A Parallel Randomized Clinical Trial.Addiction & health · 2026Article
- Nicotine replacement therapy and oral health: a network meta-analysis of adverse effects in randomized trials.Evidence-based dentistry · 2025Article
- The effectiveness of nicotine replacement therapy on oral smokeless tobacco cessation and reduction rate: A systematic review.Tobacco prevention & cessation · 2025Review
- Prevalence and Related Factors of Hypokalemia in Patients with Acute Ischemic Stroke.International journal of general medicine · 2024Article
- Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation.Internet interventions · 2015Article
- Review
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 at 4 institutions in 1 country.
Funding
Abstract
introductionSmokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users.
methodsWe conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the efficacy of 12 weeks of 4-mg nicotine lozenge for ST use.
resultsWe randomized 270 participants (136 active lozenge, 134 placebo). No significant differences were observed between the groups in biochemically confirmed all tobacco abstinence rates at Week 12 (36% lozenge vs. 27.6% placebo; odds ratio [OR] 1.5, 95% CI 0.7-2.1; p = .138). However, the 4-mg nicotine lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2-3.2; p = .011) and self-reported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2-3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), nicotine withdrawal symptoms decreased significantly with time (time effect = -.022 per day, SE = .003; p < .001) and was significantly lower for the active lozenge (treatment effect = -.213, SE = .071; p = .003). Tobacco craving also decreased significantly following TQD (time effect = -.071, SE = .006; p < .001) and was lower for the active nicotine lozenge (treatment effect = -.452, SE = .164; p = .006). DISCUSSION: The 4-mg nicotine lozenge increased self-reported but not biochemically confirmed tobacco abstinence rates at 3 months. The use of the 4-mg nicotine lozenge is associated with decreased nicotine withdrawal symptoms and tobacco craving.
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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.