Evidence map›Paper›PMID 22324516›Full record

Trial reportAlcoholism, clinical and experimental research2012

A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients.

Joanne B Fertig, Megan L Ryan, Daniel E Falk, Raye Z Litten, Margaret E Mattson, Janet Ransom, William J Rickman, Charles Scott, Domenic Ciraulo, Alan I Green and 10 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00970814 (A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 4% 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.

NCT00970814 phase2completednot on this map

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers

TypeinterventionalSponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Ran2009 to 2010Enrolled130ConditionsAlcoholismArmsBBCET, Levetiracetam XR, Sugar Pill
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  3. Anticonvulsants for alcohol dependence.The Cochrane database of systematic reviews · 2014
    Pooled it
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  11. Missing Data Sensitivity Analyses for Alcohol Research.Alcohol, clinical & experimental research · 2026
    Article
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  16. Review
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  19. Automatic avoidance tendencies for alcohol cues predict drinking after detoxification treatment in alcohol dependence.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2017
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  20. 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

20 authors at 11 institutions in 1 country.

Joanne B FertigDivision of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland, USA. jfertig@mail.nih.gov
Megan L Ryan
Daniel E Falk
Raye Z Litten
Margaret E Mattson
Janet Ransom
William J Rickman
Charles Scott
Domenic Ciraulo
Alan I Green
Nassima A Tiouririne
Bankole Johnson
Helen Pettinati
Eric C Strain
Eric Devine
Mary F Brunette
Kyle Kampman
David A Tompkins
Robert Stout
NCIG 002 Study Group
National Institutes of Health · USFast Track Drugs and Biologics · USBoston University · USUniversity of Pennsylvania · USUniversity of Virginia · USDartmouth College · USDartmouth Psychiatric Research Center · USDecision Sciences (United States) · USJohns Hopkins Medicine · USJohns Hopkins University · USSubstance Abuse and Mental Health Services Administration · US

Funding

Medications Development for Drug Abuse DisordersR01DA018125 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 2004 to 2014
$5.2M
Mentoring of Clinical Investigators in Patient Oriented ResearchK24DA023186 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 2007 to 2016
$1.8M
Intramural NIH HHS Z99 AA999999NIDA NIH HHS K24 DA023186NIDA NIH HHS R01 DA018125
6 · The paper itself

Abstract

backgroundDespite advances in the development of medications to treat alcohol dependence, few medications have been approved by the U.S. Food and Drug Administration. The use of certain anticonvulsant medications has demonstrated potential efficacy in treating alcohol dependence. Previous research suggests that the anticonvulsant levetiracetam may be beneficial in an alcohol-dependent population of very heavy drinkers.

methodsIn this double-blind, randomized, placebo-controlled clinical trial, 130 alcohol-dependent patients who reported very heavy drinking were recruited across 5 clinical sites. Patients received either levetiracetam extended-release (XR) or placebo and a Brief Behavioral Compliance Enhancement Treatment intervention. Levetiracetam XR was titrated during the first 4 weeks to 2,000 mg/d. This target dose was maintained during weeks 5 through 14 and was tapered during weeks 15 and 16.

resultsNo significant differences were detected between the levetiracetam XR and placebo groups in either the primary outcomes (percent heavy drinking days and percent subjects with no heavy drinking days) or in other secondary drinking outcomes. Treatment groups did not differ on a number of nondrinking outcomes, including depression, anxiety, mood, and quality of life. The only difference observed was in alcohol-related consequences. The levetiracetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period (p = 0.02). Levetiracetam XR was well tolerated, with fatigue being the only significantly elevated adverse event, compared with placebo (53% vs. 24%, respectively; p = 0.001).

conclusionsThis multisite clinical trial showed no efficacy for levetiracetam XR compared with placebo in reducing alcohol consumption in heavy drinking alcohol-dependent patients.

Indexed as

AdultAffectAgedAlcoholismAnticonvulsantsAnxietyBreath TestsDelayed-Action PreparationsDepressionDiagnostic and Statistical Manual of Mental DisordersDouble-Blind MethodFemaleHumansLevetiracetamMaleMiddle AgedAnticonvulsantsDelayed-Action PreparationsLevetiracetamPiracetam

Identifiers

PMID22324516
PMCPMC3355217
OpenAlexW2119106378

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

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.