Evidence map›Paper›PMID 30986535›Full record

Trial reportContemporary clinical trials2019

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON).

Mia Malone, Ryan McDonald, Alex Vittitow, Jenny Chen, Rita Obi, Daniel Schatz, Babak Tofighi, Ann Garment, Andrea Kermack, Keith Goldfeld and 4 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Availability of Medications for the Treatment of Alcohol and Opioid Use Disorder in the USA.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
  11. 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

14 authors.

Mia MaloneNew York University School of Medicine, Department of Population Health, United States of America.
Ryan McDonaldNew York University School of Medicine, Department of Population Health, United States of America.
Alex VittitowNew York University School of Medicine, Department of Population Health, United States of America.
Jenny ChenNew York University School of Medicine, Department of Population Health, United States of America.
Rita ObiNew York University School of Medicine, Department of Population Health, United States of America.
Daniel SchatzNew York University School of Medicine, Department of Population Health, United States of America.
Babak TofighiNew York University School of Medicine, Department of Population Health, United States of America; New York University School of Medicine, Department of Medicine, United States of America.
Ann GarmentNew York University School of Medicine, Department of Medicine, United States of America.
Andrea KermackMontefiore Medical Center, Department of Medicine, United States of America. Electronic address: akermack@montefiore.org.
Keith GoldfeldNew York University School of Medicine, Department of Population Health, United States of America.
Heather GoldNew York University School of Medicine, Department of Population Health, United States of America.
Eugene LaskaNew York University School of Medicine, Department of Psychiatry, United States of America.
John RotrosenNew York University School of Medicine, Department of Psychiatry, United States of America.
Joshua D LeeNew York University School of Medicine, Department of Population Health, United States of America; New York University School of Medicine, Department of Medicine, United States of America. Electronic address: joshua.lee@nyulangone.org.

Funding

Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary CareR01AA020836 · NIAAA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI LEE, JOSHUA D · 2013 to 2017
$5.3M
NIAAA NIH HHS R01 AA020836
6 · The paper itself

Abstract

backgroundExtended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders.

methodsThis pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120).

resultsWe describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported.

conclusionsXR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.

Indexed as

Primary Health CareAdultAlcoholismCost-Benefit AnalysisDelayed-Action PreparationsHumansInjections, IntramuscularMiddle AgedModels, EconometricNaltrexoneNarcotic AntagonistsSocioeconomic FactorsDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsvivitrolAlcohol dependenceAlcohol use disorderExtended-release naltrexoneMedical managementNaltrexonePrimary care treatment

Identifiers

PMID30986535
PMCPMC6701869

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.