Evidence map›Paper›PMID 24674234›Full record

Trial reportJournal of substance abuse treatment2014

An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone.

Panagiotis Vagenas, Angela Di Paola, Maua Herme, Thomas Lincoln, Daniel J Skiest, Frederick L Altice, Sandra A Springer

Erratum issued 2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of substance abuse treatment, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 10% 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.

NCT01077310 nacompletednot on this map

Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking

TypeinterventionalSponsorYale UniversityRan2010 to 2015Enrolled100ConditionsAlcohol Dependence, Problem Drinking, Hazardous Drinking, Human Immunodeficiency VirusArmsVivitrol- Intramuscular naltrexone (depot-formulation), Placebo
NCT01246401 phase1 / phase2completednot on this map

Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations

TypeinterventionalSponsorYale UniversityRan2011 to 2016Enrolled151ConditionsHIV, AIDS, Opioid Dependence, Drug DependenceArmsExtended-Release Naltrexone
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pharmacological interventions for drug-using offenders.The Cochrane database of systematic reviews · 2015
    Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Panagiotis VagenasYale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510.
Angela Di PaolaYale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510.
Maua HermeYale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510.
Thomas LincolnDepartment of Medicine, Baystate Medical Center, Springfield, MA 01199.
Daniel J SkiestDepartment of Medicine, Baystate Medical Center, Springfield, MA 01199.
Frederick L AlticeYale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510; Yale School of Public Health, Division of Epidemiology of Microbial Diseases, New Haven, CT 06510.
Sandra A SpringerYale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510. Electronic address: sandra.springer@yale.edu.
Yale University · USBaystate Medical Center · US

Funding

Naltrexone for Opioid Dependent Released HIV+ Criminal Justice PopulationsR01DA030762 · NIDA · YALE UNIVERSITY · PI SPRINGER, SANDRA ANN · 2010 to 2015
$4.1M
Alcohol Pharmacotherapies Among Released PrisonersR01AA018944 · NIAAA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS, SPRINGER, SANDRA ANN · 2009 to 2013
$3.8M
Enhancing Health Outcomes Among HIV+ Substance AbusersK24DA017072 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2003 to 2012
$1.5M
Medication Assisted Therapy as a Conduit to Care for HIV+ CJS Populations TransitK02DA032322 · NIDA · YALE UNIVERSITY · PI SPRINGER, SANDRA ANN · 2011 to 2022
$1.3M
NIAAA NIH HHS R01 AA018944NIAAA NIH HHS R01AA018944NIDA NIH HHS K02 DA032322NIDA NIH HHS K02DA032322NIDA NIH HHS K24 DA017072NIDA NIH HHS K24DA017072NIDA NIH HHS R01 DA030762NIDA NIH HHS R01DA030762
6 · The paper itself

Abstract

Extended-release naltrexone (XR-NTX), an approved treatment for opioid or alcohol dependence, is a once-monthly injectable formulation of naltrexone. Hepatotoxicity concerns have limited its use, necessitating further investigation. This study aims to examine hepatic enzyme levels in participants of 2 randomized placebo-controlled trials (RCTs) of XR-NTX. Hepatic transaminases were measured in 85 patients enrolled in RCTs of XR-NTX among HIV-infected prisoners, transitioning to the community and receiving treatment for either dependence on alcohol (52.9%), opioids (44.7%) or both (16.5%). Baseline characteristics included HCV co-infection (55.7%), antiretroviral therapy (81%), mental illness (39%) and receiving psychiatric medications (34.1%). Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) were not statistically different between persons randomized to placebo (N=24) and XR-NTX (N=61) arms. These results confirm that XR-NTX is safe to use among opioid and alcohol dependent HIV-infected released prisoners receiving ART with high rates of co-morbid HCV infection and mental illness.

Indexed as

Liver Function TestsAdultAlanine TransaminaseAlcoholismAspartate AminotransferasesDelayed-Action PreparationsFemalegamma-GlutamyltransferaseHIV InfectionsHumansLiverMaleMiddle AgedNaltrexoneNarcotic AntagonistsOpioid-Related DisordersAlanine TransaminaseAspartate AminotransferasesDelayed-Action Preparationsgamma-GlutamyltransferaseNaltrexoneNarcotic AntagonistsAlcoholCo-morbiditiesHepatotoxicityHIV/AIDSNaltrexoneOpioidsPrisoners

Identifiers

PMID24674234
PMCPMC4042403
OpenAlexW2164000900

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.