Evidence map›Paper›PMID 23946326›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2014

A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India.

Raka Jain, Sonali Jhanjee, Veena Jain, Tina Gupta, Swati Mittal, Patricia Goelz, E Paul Wileyto, Robert A Schnoll

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Smokeless tobacco cessation interventions: A systematic review.The Indian journal of medical research · 2018
    Pooled it
  4. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  5. Pooled it
  6. Interventions for smokeless tobacco use cessation.The Cochrane database of systematic reviews · 2015
    Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Challenges in Indian Women’s Readiness to Quit Smokeless Tobacco UseAsian Pacific journal of cancer prevention : APJCP · 2018
    Article
  15. Review
  16. Tobacco Cessation Treatment Pathways for Patients With Cancer: 10 Years in the Making.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Review
  17. Smoking cessation in Asians: focus on varenicline.Patient preference and adherence · 2015
    Review
  18. Article
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Raka JainNational Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India;
Sonali Jhanjee
Veena Jain
Tina Gupta
Swati Mittal
Patricia Goelz
E Paul Wileyto
Robert A Schnoll
All India Institute of Medical Sciences · INUniversity of Pennsylvania · US

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Robert H. Vonderheide · 1985 to 2026
$222.3M
University of Toronto Coordinating Genetics Core & Clinical Trial SiteU01DA020830 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI TYNDALE, RACHEL FYNVOLA · 2005 to 2014
$22.4M
Neuroimaging Abstinence and Medication ResponseP50CA143187 · NCI · UNIVERSITY OF PENNSYLVANIA · PI AUDRAIN-MCGOVERN, JANET E · 2009 to 2013
$8.6M
An Effectiveness Trial of Maintenance Therapy for Nicotine DependenceR01DA025078 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI SCHNOLL, ROBERT ADAM · 2009 to 2013
$3.1M
Efficacy of Varenicline for Smokless Tobacco Use in IndiaR21DA026404 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI SCHNOLL, ROBERT ADAM · 2010 to 2011
$385k
NCI NIH HHS P30 CA016520NCI NIH HHS P50 CA143187NIDA NIH HHS R01 DA025078NIDA NIH HHS R21 DA026404NIDA NIH HHS U01 DA020830
6 · The paper itself

Abstract

introductionThe rate of smokeless tobacco use in India is 20%; its use causes serious health problems, and no trial has assessed behavioral or pharmacological treatments for this public health concern. This trial evaluated varenicline for treating smokeless tobacco dependence in India.

methodsThis was a double-blind placebo-controlled randomized trial of varenicline (12 weeks, 1mg, twice per day) with 237 smokeless tobacco users in India. All participants received behavioral counseling. Outcomes included self-reported and biochemically verified abstinence at the end of treatment (EOT), lapse and recovery events, safety, and medication adherence.

resultsSelf-reported EOT abstinence was significantly greater for varenicline (43%) versus placebo (31%; adjusted odds ratio [AOR] = 2.6, 95% CI = 1.2-4.2, p = .009). Biochemically confirmed EOT abstinence was greater for varenicline versus placebo (25.2% vs. 19.5%), but this was not statistically different (AOR = 1.6, 95% CI = 0.84-3.1, p = .15). Compared with placebo, varenicline did not reduce the risk for a lapse (hazard ratio [HR] = 0.86, 95% CI = 0.69-1.1, p = .14), but it did increase the likelihood of recovery to abstinence (HR = 1.2, 95% CI = 1.02-1.4, p = .02). Greater adherence increased EOT cessation rates for varenicline (39% vs. 18%, p = .003) but not for placebo (28% vs. 14%, p = .06). There were no significant differences between varenicline and placebo in rate of side effects, serious adverse events, hypertension, or stopping or reducing medication.

conclusionsVarenicline is safe for treating smokeless tobacco dependence in India, and further examination of this medication for this important public health problem is warranted.

Indexed as

AdultBenzazepinesDouble-Blind MethodFemaleHumansIndiaMalePlacebo EffectQuinoxalinesSmoking CessationTobacco, SmokelessTobacco Use DisorderVareniclineYoung AdultBenzazepinesQuinoxalinesVarenicline

Identifiers

PMID23946326
PMCPMC3864491
OpenAlexW2045459335

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.