Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2011
A pilot study of the efficacy of varenicline for the treatment of smokeless tobacco users in Midwestern United States.
Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00813917 (Varenicline for the Treatment of Smokeless Tobacco Use), which is not on this map. Cited by 15 papers, 8 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.
Varenicline for the Treatment of Smokeless Tobacco Use
Who cites it
15 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- 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
- Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016Pooled it
- Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of the American Heart Association · 2016Pooled it
- Interventions for smokeless tobacco use cessation.The Cochrane database of systematic reviews · 2015Pooled it
- Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2015Pooled it
- Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2012Pooled it
- 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
- Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India.Journal of psychoactive drugsTrial
- The Effects of Alpha Linolenic Acid (Omega-3 Fatty Acid) on Tobacco Craving Intensity, Withdrawal Symptoms and Biochemical Markers in Tobacco Users.Indian journal of clinical biochemistry : IJCB · 2025Article
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- 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.
Funding
Abstract
introductionLong-term smokeless tobacco (ST) use is known to increase the risk for oropharyngeal cancer, heart attack, and stroke. Varenicline has recently been demonstrated to increase ST abstinence rates among Swedish snus users. We have conducted a pilot study to obtain preliminary evidence of efficacy of varenicline for the treatment of ST users in Midwestern United States.
methodsWe conducted a randomized, placebo-controlled Phase II clinical trial to evaluate the potential efficacy of 12 weeks of varenicline for the treatment of ST users with an a priori decision rule that a 1-tailed p < .20 for the comparison of the primary endpoint was evidence to conclude that future studies were warranted. Subjects were followed for 6 months after randomization.
resultsWe randomized 76 subjects (38 varenicline and 38 placebo). Subjects were similar at baseline with a mean age of 41 years, and all were male. The biochemically confirmed point prevalence tobacco abstinence rates at end of treatment were 55.3% for varenicline and 42.1% for placebo (p = .126) and 47.4% and 31.6% (p = .080), respectively, at 6 months. Point prevalence ST abstinence rates at end of treatment for varenicline were 57.9% and 42.1% for placebo (p = .084) and 57.9% and 31.6% (p = .011), respectively, at 6 months. Varenicline was associated with significantly less craving compared with placebo. Varenicline was well tolerated with nausea and sleep disturbance being the most common side effects.
conclusionsVarenicline decreases craving and may be effective for increasing tobacco abstinence rates among ST users. Larger trials may be warranted to confirm these results.
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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.