Evidence map›Paper›PMID 33352487›Full record

Trial reportDrug and alcohol dependence2021

An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis.

Mary M Mitchell, Robert P Schwartz, Tse-Hwei Choo, Martina Pavlicova, Kevin E O'Grady, Jan Gryczynski, Maxine L Stitzer, Edward V Nunes, John Rotrosen

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug and alcohol dependence, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 27% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Long-Acting injectable buprenorphine PLGA microparticle formulation.International journal of pharmaceutics · 2025
    Article
  4. Article
  5. Review
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

9 authors at 5 institutions in 1 country.

Mary M MitchellFriends Research Institute, Baltimore, MD, USA. Electronic address: mmitchell@friendsresearch.org.
Robert P SchwartzFriends Research Institute, Baltimore, MD, USA.
Tse-Hwei ChooNew York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10031, USA.
Martina PavlicovaDepartment of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th St, New York, NY, 10032, USA.
Kevin E O'GradyDepartment of Psychology, University of Maryland, College Park, College Park, MD, 20742, USA.
Jan GryczynskiFriends Research Institute, Baltimore, MD, USA.
Maxine L StitzerFriends Research Institute, Baltimore, MD, USA.
Edward V NunesNew York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10031, USA.
John RotrosenNew York University School of Medicine, 550 1st Avenue, New York, NY, 10016, USA.
Friends Research Institute · USNew York State Psychiatric InstituteColumbia University · USNew York University · USUniversity of Maryland, College Park · US

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
NIDA NIH HHS UG1 DA013035
6 · The paper itself

Abstract

backgroundThe distinct pharmacological properties and clinical uses of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) present challenges in analyzing patient outcomes.

methodsWe conducted a secondary analysis of a multi-site randomized trial comparing XR-NTX with sublingual BUP-NX treatment for opioid use disorder initiated during inpatient detoxification and continued in outpatient treatment. Urine testing data for non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received all XR-NTX doses or all BUP-NX prescriptions). The present analyses sought to identify differences in the weekly percentages of opioid-positive urine tests between participants treated with the two medications.

resultsThe proportion of opioid-positive tests in both conditions was less than 20 % for 21 of the 22 weeks in the per-protocol sample and all 22 weeks in the completers sample. Generalized linear mixed model analyses revealed a significant treatment (XR-NTX vs. BUP-NX) X week (weeks 3-24) interaction in the per-protocol sample but not the completers sample. In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks.

conclusionsLongitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. Results from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample.

Indexed as

Administration, SublingualAdultAmbulatory CareAnalgesics, OpioidBuprenorphine, Naloxone Drug CombinationDelayed-Action PreparationsFemaleHumansInjections, IntramuscularMaleNaltrexoneNarcotic AntagonistsOpioid-Related DisordersAnalgesics, OpioidBuprenorphine, Naloxone Drug CombinationDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsBuprenorphine-naloxoneExtended-release naltrexoneMedication adherenceOpioid use disorder treatmentOpioid use during treatmentRandomized controlled trial

Identifiers

PMID33352487
PMCPMC8034542
OpenAlexW3110775636

What OpenQuestion holds

Textmetadata
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.