Evidence map›Paper›PMID 23728065›Full record

Trial reportJournal of addiction medicine

A double-blind, placebo-controlled trial assessing the efficacy of varenicline tartrate for alcohol dependence.

Raye Z Litten, Megan L Ryan, Joanne B Fertig, Daniel E Falk, Bankole Johnson, Kelly E Dunn, Alan I Green, Helen M Pettinati, Domenic A Ciraulo, Ofra Sarid-Segal and 8 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 150 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 7 pooled it
12.6field-weighted citation impact, top 1% 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

150 citing papers in PubMed, 7 syntheses or guidelines pooled it, 288 citations in OpenAlex.

  1. Pooled it
  2. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Efficacy of Varenicline in the Treatment of Alcohol Dependence: An Updated Meta-Analysis and Meta-Regression.International journal of environmental research and public health · 2023
    Pooled it
  5. Pooled it
  6. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Alcohol use disorder severity moderates clinical response to varenicline.Alcoholism, clinical and experimental research · 2021
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

90 more citing papers are in PubMed but not listed here.

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

18 authors at 8 institutions in 2 countries.

Raye Z LittenFrom the Division of Treatment and Recovery Research (RZL, MLR, JBF DEF), National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD; Department of Psychiatric Medicine (BJ, NAT), University of Virginia, Charlottesville, VA; Johns Hopkins University School of Medicine (KED, ECS), Baltimore, MD; Geisel School of Medicine at Dartmouth (AIG, MFB), Lebanon, NH; University of Pennsylvania Treatment Research Center (HMP, KK), Philadelphia, PA; Boston University School of Medicine (DAC, OS-S), Boston, MA; Fast Track Drugs and Biologics (JR, CS), North Potomac, MD; and Decision Sciences Institute/Pacific Institute for Research and Evaluation (RS), Pawtucket, RI. NCIG Study Group members are as follows: Boston Medical Center, Boston, MA and Quincy, MA (Joanna Piechniczek-Buczek, MD, Chris Streeter, MD, Eric Devine, PhD, Courtney Richambault, Laurie Sickles-Colaneri, RN); University of Virginia, Charlottesville, VA (Eva Jenkins-Mendoza, Sean Sembrowich, RN, Jennifer Kim Penberthy, PhD, Amanda Nizam, Nicole Fischer, Shari Steinman, Mindy Borszich); University of Virginia, Richmond, VA (Esther Makanjuola, RN, Tricia Schirmer, Kathryn Polak, Christina Hill, Kathryn Conley, Alison Eonta, Kasy Serdar, Aubrey Gartner, Amy Madigan); Geisel School of Medicine at Dartmouth, Hanover, NH and Bedford, NH (Audrey Kern, MD, Christopher O'Keefe, MS, Mirranda Boshart, Suzanne Miller, Shannon Rondeau, RN, Marjorie Weeks, Pamela Geiger); University of Pennsylvania, Treatment Research Center, Philadelphia, PA (Jennifer Plebani, PhD, William Dundon, PhD, Elizabeth Mahoney, MA, Gail Kaempf, CRPN, Brenda Beitler, APRN, Cynthia Clark, CPRN, Kelly Griffin, Joshua Lachewitz, Elizabeth Wilson, Margo Hendrickson, Tamara Roth, Laurie Downing, NP); and Johns Hopkins University School of Medicine (Joseph Harrison, MS, Kimberly Nelson, LPN, Ashley Bathgate, Connie Lowery, RN, Elana Schwartz, Torran Claiborne, Sarah Hersh).
Megan L Ryan
Joanne B Fertig
Daniel E Falk
Bankole Johnson
Kelly E Dunn
Alan I Green
Helen M Pettinati
Domenic A Ciraulo
Ofra Sarid-Segal
Kyle Kampman
Mary F Brunette
Eric C Strain
Nassima A Tiouririne
Janet Ransom
Charles Scott
Robert Stout
NCIG (National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group) Study Group
National Institutes of Health · USCalifornia University of Pennsylvania · USDartmouth College · USFast Track Drugs and Biologics · USUniversity of Virginia · USBoston University · USInstitute for Research and Evaluation · USJohns Hopkins University · US

Funding

Mentoring of Clinical Investigators in Patient Oriented ResearchK24DA023186 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 2007 to 2016
$1.8M
NICHD NIH HHS HHSN275200900005CNIDA NIH HHS K24 DA023186PHS HHS HHSN27200900005C
6 · The paper itself

Abstract

objectivesTo assess the efficacy and safety of varenicline (Chantix) for the treatment of alcohol dependence. Varenicline is a partial α4β2 nicotinic acetylcholine agonist approved by the Food and Drug Administration for smoking cessation. It has reduced drinking in animal studies and in small studies of humans who were both heavy drinkers and smokers. This is the first multisite clinical trial of varenicline in a population of smokers and nonsmokers with alcohol dependence.

methodsMen and women (n = 200) meeting the criteria for alcohol dependence were recruited across 5 clinical sites. Patients received double-blind varenicline or placebo and a computerized behavioral intervention. Varenicline was titrated during the first week to 2 mg/d, which was maintained during weeks 2 to 13.

resultsThe varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference = 10.4), drinks per day, drinks per drinking day, and alcohol craving compared with the placebo group (P < 0.05). The average treatment effect on alcohol use was similar for smokers and nonsmokers. Varenicline was well-tolerated; adverse events were expected and mild.

conclusionsVarenicline significantly reduced alcohol consumption and craving, making it a potentially viable option for the treatment of alcohol dependence.

Indexed as

AdultAlcoholismBenzazepinesDouble-Blind MethodFemaleHumansMaleMedication AdherenceMiddle AgedQuinoxalinesTreatment OutcomeVareniclineBenzazepinesQuinoxalinesVarenicline

Identifiers

PMID23728065
PMCPMC3914416
OpenAlexW2006833508

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.