Evidence map›Paper›PMID 25742208›Full record

Trial reportThe Journal of clinical psychiatry2015

Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety.

Stephanie S O'Malley, William R Corbin, Robert F Leeman, Kelly S DeMartini, Lisa M Fucito, Jolomi Ikomi, Denise M Romano, Ran Wu, Benjamin A Toll, Kenneth J Sher and 2 more

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

Trial report in The Journal of clinical psychiatry, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00568958 (Naltrexone for Heavy Drinking in Young Adults), which is not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 3% 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.

NCT00568958 phase4completednot on this map

Naltrexone for Heavy Drinking in Young Adults

TypeinterventionalSponsorYale UniversityRan2008 to 2012Enrolled140ConditionsAlcohol Consumption, Alcoholic Intoxication, Alcoholism, Alcohol-induced DisordersArmsBASICS counseling, naltrexone, placebo naltrexone
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.

  1. Pooled it
  2. A Randomized Controlled Trial of N-acetylcysteine for Adolescent and Young Adult Alcohol Use Disorder.Journal of the American Academy of Child and Adolescent Psychiatry · 2026
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  4. Genetically influenced externalizing and internalizing risk pathways as novel prevention targets.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Stephanie S O'MalleyConnecticut Mental Health Center, 34 Park St, New Haven, CT 06519 Stephanie.omalley@yale.edu.
William R Corbin
Robert F Leeman
Kelly S DeMartini
Lisa M Fucito
Jolomi Ikomi
Denise M Romano
Ran Wu
Benjamin A Toll
Kenneth J Sher
Ralitza Gueorguieva
Henry R Kranzler
Yale University · USConnecticut Mental Health Center · US

Funding

Alcohol and Behavioral Risks Throughout CollegeR01AA013967 · NIAAA · UNIVERSITY OF TEXAS AUSTIN · PI FROMME, KIM · 2003 to 2009
$3.3M
Naltrexone for Heavy Drinking in Young AdultsR01AA016621 · NIAAA · YALE UNIVERSITY · PI O'MALLEY, STEPHANIE S · 2007 to 2011
$3.0M
Alcohol and Adult Development: Understanding Etiology and ConsequencesK05AA017242 · NIAAA · UNIVERSITY OF MISSOURI-COLUMBIA · PI SHER, KENNETH JAMES · 2007 to 2016
$2.1M
Improving Alcoholism TreatmentK05AA014715 · NIAAA · YALE UNIVERSITY · PI O'MALLEY, STEPHANIE S · 2004 to 2013
$2.1M
Novel Approaches to Alcoholism Pharmacotherapy and RiskK24AA013736 · NIAAA · UNIVERSITY OF PENNSYLVANIA · PI KRANZLER, HENRY RICHARD · 2002 to 2012
$1.5M
New Approaches to Smoking Cessation in Heavy DrinkersK23AA020000 · NIAAA · YALE UNIVERSITY · PI FUCITO, LISA M · 2011 to 2016
$755k
Difficulties with Self-Control and High-Risk Alcohol Use in Young AdultsK01AA019694 · NIAAA · YALE UNIVERSITY · PI LEEMAN, ROBERT F · 2010 to 2014
$705k
NIAAA NIH HHS K01 AA019694NIAAA NIH HHS K05 AA014715NIAAA NIH HHS K05 AA017242NIAAA NIH HHS K05 AA01742NIAAA NIH HHS K23 AA020000NIAAA NIH HHS K24 AA013736NIAAA NIH HHS R01 AA013967NIAAA NIH HHS R01 AA016621
6 · The paper itself

Abstract

objectiveNaltrexone, an opioid antagonist, may facilitate reduction in drinking among young adults. We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in young adults who engage in heavy drinking.

methodA randomized, double-blind, placebo-controlled study was conducted in an outpatient research center in March 2008-January 2012. Participants were aged 18-25 years and reported ≥ 4 heavy drinking days in the prior 4 weeks. Interventions included naltrexone 25 mg daily plus 25 mg targeted (at most daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n = 67). All participants received a personalized feedback session and brief counseling every other week. Primary outcomes were percent heavy drinking days and percent days abstinent over the 8-week treatment period. Secondary outcomes included number of drinks per drinking day and percentage of days with estimated blood alcohol concentration (BAC) levels ≥ 0.08 g/dL.

resultsOf 140 randomized patients, 128 began treatment, comprising the evaluable sample. During treatment, percent heavy drinking days (naltrexone: mean = 21.60, SD = 16.05; placebo: mean = 22.90, SD = 13.20) (P = .58) and percent days abstinent (naltrexone: mean = 56.60, SD = 22.52; placebo: mean = 62.50, SD = 15.75) (P = .39) did not differ by group. Naltrexone significantly reduced the number of drinks per drinking day (naltrexone: mean = 4.90, SD = 2.28; placebo: mean = 5.90, SD = 2.51) (P = .009) and percentage of drinking days with estimated BAC ≥ 0.08 g/dL (naltrexone: mean = 35.4, SD = 28.40; placebo: mean = 45.7, SD = 26.80) (P = .042). There were no serious adverse events. Sleepiness was more common with naltrexone.

conclusionsNaltrexone did not reduce frequency of drinking or heavy drinking days, but reduced secondary measures of drinking intensity. While effects were modest, the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce the amount of alcohol they drink.

trial registrationClinicalTrials.gov identifier: NCT00568958.

Indexed as

AdolescentAlcohol DrinkingAlcoholismCombined Modality TherapyDose-Response Relationship, DrugDouble-Blind MethodEthanolFemaleHumansMaleMotivational InterviewingNaltrexoneSocial FacilitationYoung AdultEthanolNaltrexone

Identifiers

PMID25742208
PMCPMC4442987
OpenAlexW2002623313

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.