Evidence map›Paper›PMID 26317285›Full record

Trial reportJournal of psychoactive drugs

Biochemical Validation of Self-Reported Smokeless Tobacco Abstinence among Smokeless Tobacco Users: Results from a Clinical Trial of Varenicline in India.

Raka Jain, Sonali Jhanjee, Veena Jain, Tina Gupta, Swati Mittal, Prashant Chauhan, Rahul Raghav, Patricia Goelz, Robert A Schnoll

Abstract readClinical Trial, Phase IIRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Journal of psychoactive drugs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Interventions for tobacco cessation delivered by dental professionals.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Tobacco Use and Subsequent Cessation Among Hospitalized Patients in Mumbai, India: A Longitudinal Study.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020
    Observational
  9. Article
  10. Article
  11. Article
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

9 authors at 1 institution in 1 country.

Raka Jaina National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
Sonali Jhanjeea National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
Veena Jainb Centre for Dental Education and Research , All India Institute of Medical Sciences , New Delhi , India.
Tina Guptaa National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
Swati Mittalb Centre for Dental Education and Research , All India Institute of Medical Sciences , New Delhi , India.
Prashant Chauhana National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
Rahul Raghava National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
Patricia Goelzc Department of Psychiatry and Abramson Cancer Center , University of Pennsylvania , Philadelphia , PA.
Robert A Schnollc Department of Psychiatry and Abramson Cancer Center , University of Pennsylvania , Philadelphia , PA.
All India Institute of Medical Sciences · IN

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

The validity of self-reported tobacco use is often questioned given the potential for underestimation of use. This study used data from a double-blind, placebo-controlled clinical trial of varenicline for smokeless tobacco dependence in India to evaluate the accuracy of self-reported smokeless tobacco cessation using biochemical validation procedures and to evaluate correlates of reporting inaccuracy. Smokeless tobacco users attending a dental clinic at AIIMS were randomized to placebo or varenicline; all participants received counseling. Detailed smokeless tobacco use was recorded and abstinence was defined as cotinine-verified 7-day point prevalence cessation (cotinine < 50 ng/ml) and breath CO > 10 ppm at the end of 12 weeks of treatment. One-half of study completers (82/165) self-reported abstinence. Biochemical verification confirmed that (65.9%) subjects provided accurate self-reports while (34.1%) participants underreported tobacco use. These data indicate poor agreement between self-reported and biochemically confirmed abstinence (κ = -0.191). Underreporters of tobacco use had significantly higher baseline cotinine (p < 0.05), total craving (p < 0.012), and negative reinforcement craving (p < 0.001) vs. those whose self-reports were correctly verified. These findings provide evidence to support the need for biochemical validation of self-reported abstinence outcomes among smokeless tobacco users in cessation programs in India and identify high levels of pretreatment cotinine and craving levels as potential correlates of false reporting.

Indexed as

Self ReportAdultBreath TestsCarbon MonoxideCotinineDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleHumansIndiaMaleNicotinic AgonistsTobacco Use CessationTobacco Use DisorderVareniclineCarbon MonoxideCotinineNicotinic AgonistsVareniclinebiochemical validationself-reportsmokeless tobacco usersurinevarenicline

Identifiers

PMID26317285
PMCPMC4698153
OpenAlexW1922611948

What OpenQuestion holds

Textmetadata
LicenceTDM
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.