Evidence map›Paper›PMID 25240704›Full record

Trial reportContemporary clinical trials2014

Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community.

Angela Di Paola, Thomas Lincoln, Daniel J Skiest, Maureen Desabrais, Frederick L Altice, Sandra A Springer

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01246401 (Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 7% 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.

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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Interventions for female drug-using offenders.The Cochrane database of systematic reviews · 2019
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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

6 authors at 2 institutions in 1 country.

Angela Di PaolaYale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, 135 College St., Suite 323, New Haven, CT 06510, United States.
Thomas LincolnDepartment of Medicine, Baystate Medical Center, Springfield, MA, United States.
Daniel J SkiestDepartment of Medicine, Baystate Medical Center, Springfield, MA, United States.
Maureen DesabraisDepartment of Medicine, Baystate Medical Center, Springfield, MA, United States.
Frederick L AlticeYale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, 135 College St., Suite 323, New Haven, CT 06510, United States; Yale University School of Public Health, Division of Epidemiology of Microbial Diseases, 135 College St., Suite 323, New Haven, CT 06510, United States.
Sandra A SpringerYale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, 135 College St., Suite 323, New Haven, CT 06510, United States. Electronic address: sandra.springer@yale.edu.
Baystate Medical Center · USYale University · US

Funding

Using Coincidence Analysis to Investigate Factors Affecting PrEP Initiation and Continuation in Southern ending the Epidemic CountiesP30MH062294 · NIMH · YALE UNIVERSITY · PI Raul Ulises Hernandez · 2001 to 2026
$48.5M
Naltrexone for Opioid Dependent Released HIV+ Criminal Justice PopulationsR01DA030762 · NIDA · YALE UNIVERSITY · PI SPRINGER, SANDRA ANN · 2010 to 2015
$4.1M
Direct/Observed Therapy/Community-Released HIV+PrisonersR01DA017059 · NIDA · YALE UNIVERSITY · PI ALTICE, FREDERICK LEWIS · 2004 to 2008
$3.3M
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
NIDA NIH HHS K02 DA032322NIDA NIH HHS K24 DA017059NIDA NIH HHS K24 DA017072NIDA NIH HHS R01 DA017059NIDA NIH HHS R01 DA030762NIMH NIH HHS P30 MH062294
6 · The paper itself

Abstract

backgroundPeople with opioid dependence and HIV are concentrated within criminal justice settings (CJS). Upon release, however, drug relapse is common and contributes to poor HIV treatment outcomes, increased HIV transmission risk, reincarceration and mortality. Extended-release naltrexone (XR-NTX) is an evidence-based treatment for opioid dependence, yet is not routinely available for CJS populations.

methodsA randomized, double-blind, placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes.

resultsWe describe the methods and early acceptability of this trial. In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified. Study acceptability was modest, with 132 (66%) persons who consented to participate from 199 total referrals. Overall, 79% of the participants had previously received opioid agonist treatment before this incarceration. Thus far, 65 (49%) of those agreeing to participate in the trial have initiated XR-NTX or placebo. Of the 134 referred patients who ultimately did not receive a first injection, the main reasons included a preference for an alternative opioid agonist treatment (37%), being ineligible (32%), not yet released (10%), and lost upon release before receiving their injection (14%).

conclusionsStudy findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community. The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments. CLINICAL TRIAL NUMBER: NCT01246401.

Indexed as

PrisonersCommunicationDelayed-Action PreparationsDouble-Blind MethodFemaleHIV InfectionsHumansInjections, IntramuscularMaleNaltrexoneNarcotic AntagonistsOpioid-Related DisordersPatient ComplianceResearch DesignRisk-TakingTime FactorsDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsExtended-release naltrexoneHIVOpioid dependencePrisonersRandomized controlled trialVivitrol

Identifiers

PMID25240704
PMCPMC4283549
OpenAlexW1969473587

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.