Evidence map›Paper›PMID 35129242›Full record

Trial reportAddiction (Abingdon, England)2022

HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.

P Todd Korthuis, Ryan R Cook, Paula J Lum, Elizabeth Needham Waddell, Hansel Tookes, Pamela Vergara-Rodriguez, Lynn E Kunkel, Gregory M Lucas, Allan E Rodriguez, Sarann Bielavitz and 11 more

Open access · greenAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Comorbidities of substance use: Opportunities realized and future needs.Journal of substance use and addiction treatment · 2026
    Article
  8. Article
  9. Article
  10. Article
  11. Medications for OUD: Extended-Release Naltrexone.Current addiction reports · 2025
    Article
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Article
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

21 authors at 10 institutions in 1 country.

P Todd KorthuisAddiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.ORCID 0000-0001-5556-3597
Ryan R CookAddiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.ORCID 0000-0001-8754-995X
Paula J LumDivision of HIV, ID and Global Medicine, University of California, San Francisco, CA, USA.
Elizabeth Needham WaddellAddiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.ORCID 0000-0002-0701-1939
Hansel TookesDivision of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.
Pamela Vergara-RodriguezRuth M. Rothstein CORE Center, Department of Psychiatry and Department of Internal Medicine, Cook County Health, Chicago, IL, USA.
Lynn E KunkelAddiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.
Gregory M LucasJohns Hopkins School of Medicine, Baltimore, MD, USA.
Allan E RodriguezDivision of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.
Sarann BielavitzAddiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.ORCID 0000-0003-2104-6991
Laura C FanucchiDivision of Infectious Diseases and Center on Drug and Alcohol Research, University of Kentucky, Lexington, KY, USA.
Kim A HoffmanOregon Health and Science University-Portland State University School of Public Health, Portland, OR, USA.
Ken BachrachTarzana Treatment Centers, Tarzana, CA, USA.
Elizabeth H PayneEmmes Company, LLC, Rockville, MD, USA.
Julia A CollinsEmmes Company, LLC, Rockville, MD, USA.
Abigail MatthewsEmmes Company, LLC, Rockville, MD, USA.
Neal OdenEmmes Company, LLC, Rockville, MD, USA.
Petra JacobsNational Institutes of Health, National Institute on Aging, Bethesda, MD, USA.
Eve JelstromEmmes Company, LLC, Rockville, MD, USA.
James L SorensenDepartment of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
Dennis McCartyAddiction Medicine Program, Oregon Health and Science University, Portland, OR, USA.ORCID 0000-0001-9014-2894
Emmes (United States) · USPortland State University · USOregon Health & Science University · USUniversity of California, San Francisco · USUniversity of Miami · USJohns Hopkins University · USNational Institutes of Health · USRuth M. Rothstein CORE Center · USTarzana Treatment Centers · USUniversity of Kentucky · US

Funding

The Ohio Valley Node of the Clinical Trials Network (CTN-0153)UG1DA013732 · NIDA · UNIVERSITY OF CINCINNATI · PI T John WINHUSEN · 2015 to 2026
$42.5M
Western States Node of the National Drug Abuse Treatment Clinical Trials Network (TMS for CUD) UG1DA015815 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Keith N. Humphreys, Philip Todd Korthuis · 2015 to 2026
$24.6M
Peer-based Retention of people who Use Drugs in Rural Research (PROUD-R2)U01TR002631 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI KORTHUIS, PHILIP TODD, YOUNG, APRIL MARIE · 2018 to 2023
$5.2M
NW Center of Excellence & K12 in Patient Centered Learning Health Systems ScienceK12HS026370 · AHRQ · OREGON HEALTH & SCIENCE UNIVERSITY · PI EDEN, KAREN BEEKMAN, GUISE, JEANNE-MARIE · 2018 to 2022
$4.0M
Treatment outcomes and comorbidity in HIV-infected IDUK24DA035684 · NIDA · JOHNS HOPKINS UNIVERSITY · PI LUCAS, GREGORY M · 2014 to 2024
$1.5M
AHRQ HHS K12 HS026370NCATS NIH HHS U01 TR002631NIDA NIH HHS K24 DA035684NIDA NIH HHS UG1 DA013732NIDA NIH HHS UG1 DA015815
6 · The paper itself

Abstract

BACKGROUND AND

aimOpioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results.

designOpen-label, non-inferiority randomized trial.

settingSix US HIV primary care clinics.

participantsA total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment.

interventionHIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59). MEASUREMENTS: Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks.

findingsFewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2).

conclusionsA randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.

Indexed as

HIV InfectionsOpioid-Related DisordersAnalgesics, OpioidDelayed-Action PreparationsFemaleHumansInjections, IntramuscularMaleNaltrexoneNarcotic AntagonistsAnalgesics, OpioidDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsBuprenorphineextended-release naltrexoneHIVmethadonenon-inferiority trialopioid-related disordersrandomized controlled trials

Identifiers

PMID35129242
PMCPMC9314106
OpenAlexW4210926571

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.