Evidence map›Paper›PMID 26317176›Full record

Trial reportJournal of psychoactive drugs

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.

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

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 35% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Challenges in Indian Women’s Readiness to Quit Smokeless Tobacco UseAsian Pacific journal of cancer prevention : APJCP · 2018
    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

7 authors at 1 institution in 1 country.

Sonali Jhanjeea National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
Raka Jaina 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 Mittala 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

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 P50 CA143187NIDA NIH HHS R01 DA025078NIDA NIH HHS R21 DA026404
6 · The paper itself

Abstract

This study examined changes in tobacco craving, withdrawal, and affect as correlates of efficacy in a phase-2 clinical trial of varenicline for smokeless tobacco dependence in India. Smokeless tobacco users (N = 237) at the All India Institute of Medical Sciences were randomized to placebo or varenicline. Abstinence was defined as cotinine-verified seven-day point prevalence cessation at end of treatment (EOT). General Linear Model repeated measures assessed the effects of treatment condition, time, abstinence state, and interaction effects on changes in craving, withdrawal, positive (PA) and negative affect (NA) from baseline to EOT. All participants showed a significant reduction in withdrawal (p < .001), total craving (p < .001), positive reinforcement (PR) craving (p < .001), and NA (p = .02), and an increase in PA (p = .04) from baseline to EOT. However, there were no differences between placebo and varenicline participants in measures of withdrawal, craving, or affect from baseline to week 3 or at EOT. Significant interactions between time and abstinence state were found for total craving (p = .008), PR craving (p < .001), and withdrawal (p = .001), indicating reductions in these processes among those abstinent vs. those still chewing smokeless tobacco. Additional research is needed concerning the effects of varenicline on craving, withdrawal, and affect among smokeless tobacco users.

Indexed as

AdultAffectCravingDouble-Blind MethodFemaleHumansIndiaMaleNicotinic AgonistsSubstance Withdrawal SyndromeTobacco Use CessationTobacco Use DisorderVareniclineNicotinic AgonistsVareniclineinterventionsmokeless tobaccotreatmentvarenicline

Identifiers

PMID26317176
PMCPMC4699413
OpenAlexW1910202113

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.