Evidence map›Paper›PMID 31313402›Full record

Trial reportAddiction (Abingdon, England)2020

Opioid use and dropout from extended-release naltrexone in a controlled trial: implications for mechanism.

Edward V Nunes, Adam Bisaga, Evgeny Krupitsky, Narinder Nangia, Bernard L Silverman, Sarah C Akerman, Maria A Sullivan

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Medications for OUD: Extended-Release Naltrexone.Current addiction reports · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Medications Development for Treatment of Opioid Use Disorder.Cold Spring Harbor perspectives in medicine · 2021
    Review
  10. Article
  11. Article
  12. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Edward V NunesNew York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.ORCID 0000-0002-2055-3425
Adam BisagaNew York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.ORCID 0000-0003-4243-6462
Evgeny KrupitskySt Petersburg Pavlov State Medical University, St Petersburg, Russia.ORCID 0000-0002-0529-4525
Narinder NangiaAlkermes, Inc., Waltham, MA, USA.ORCID 0000-0002-7303-6659
Bernard L SilvermanAlkermes, Inc., Waltham, MA, USA.ORCID 0000-0002-5833-0147
Sarah C AkermanAlkermes, Inc., Waltham, MA, USA.ORCID 0000-0003-0866-5245
Maria A SullivanNew York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.ORCID 0000-0003-1940-9060

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
Drug Abuse Treatment Development and Research MentoringK24DA022412 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI NUNES, EDWARD V. · 2007 to 2016
$1.7M
Alkermes, Inc.NIDA NIH HHS K24 DA022412NIDA NIH HHS UG1 DA013035
6 · The paper itself

Abstract

BACKGROUND AND

aimsExtended-release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post-hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo-controlled trial of extended-release injection naltrexone (XR-NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness.

designThis was a 24-week multiple-site, double-blind, randomized trial of monthly XR-NTX versus placebo injections. We analyzed time to dropout from treatment using survival analysis with an extended Cox model as a function of treatment (XR-NTX versus placebo) and with weekly urine drug test (UDT) results for opioids at each week as a time-dependent covariate.

settingThirteen addiction treatment programs in Russia, 2008-09.

participantsA total of 250 adults with opioid use disorder who had completed in-patient detoxification.

interventionXR-NTX injection or placebo injection every 4 weeks with weekly clinic visits and biweekly counseling. MEASUREMENTS: Urine toxicology for opioids measured weekly and week of dropout from treatment.

findingsThe Cox model yielded a significant interaction of time-dependent urine toxicology by treatment (P = 0.024). Among patients receiving placebo, a positive UDT in a given week increased the risk for dropout from treatment in the subsequent week [hazard ratio (HR) = 6.25; 95% confidence interval (CI) = 3.6-10.0], whereas among patients receiving XR-NTX, a positive UDT result showed no significant effect on risk for dropout (HR = 1.67; 95% CI = 0.6-4.5). The proportion of patients who completed all 24 weeks without any positive UDT result was 31% on XR-NTX compared with 20% on placebo (P = 0.051).

conclusionsExtended-release injection naltrexone was effective at reducing the risk of dropout from opioid use disorder treatment after an episode of opioid use. Just under a third of patients (31%) on XR-NTX had no opioid-positive urine tests across the trial, but the hypothesis that this would differ from placebo (20%) was not confirmed.

Indexed as

AdultAmbulatory CareDelayed-Action PreparationsDouble-Blind MethodDuration of TherapyFemaleHumansMaleNaltrexoneNarcotic AntagonistsOpioid-Related DisordersPatient DropoutsRussiaSurvival AnalysisTreatment OutcomeDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsDropoutextended-release naltrexonemedication-assisted treatmentopioid dependenceopioid use disorderrelapse

Identifiers

PMID31313402
PMCPMC6980175

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

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.