Evidence map›Paper›PMID 30336703›Full record

Trial reportThe American journal of psychiatry2019

A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder.

Maria A Sullivan, Adam Bisaga, Martina Pavlicova, Kenneth M Carpenter, C Jean Choi, Kaitlyn Mishlen, Frances R Levin, John J Mariani, Edward V Nunes

Open access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The American journal of psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 4 pooled it
9.9field-weighted citation impact, top 2% 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

40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Should Residents Be Required to Administer Long-Acting Injectables?Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry · 2026
    Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Medications for OUD: Extended-Release Naltrexone.Current addiction reports · 2025
    Article
  14. Article
  15. Article
  16. Informing evidence-based medicine for opioid use disorder using pharmacoeconomic studies.Expert review of pharmacoeconomics & outcomes research · 2024
    Review
  17. Article
  18. Review
  19. Review
  20. 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 1 institution in 1 country.

Maria A SullivanFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Adam BisagaFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Martina PavlicovaFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Kenneth M CarpenterFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
C Jean ChoiFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Kaitlyn MishlenFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Frances R LevinFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
John J MarianiFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Edward V NunesFrom the Division on Substance Use, Department of Psychiatry, Columbia University and New York State Psychiatric Institute, New York; the Mailman School of Public Health, Columbia University, New York; and Alkermes, Waltham, Mass.
Columbia University · US

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
Translational Clinical Research Fellowship on Substance Use DisordersT32DA007294 · NIDA · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI Frances Rudnick Levin, Diana M Martinez · 1993 to 2026
$9.3M
OPIATE DEPENDENCE: COMBINED NALTREXONE/BEHAVIOR THERAPYR01DA010746 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI SULLIVAN, MARIA A · 1997 to 2008
$4.3M
Substance Abuse Treatment Development and Clinical Research MentoringK24DA029647 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LEVIN, FRANCES RUDNICK · 2010 to 2019
$1.8M
Drug Abuse Treatment Development and Research MentoringK24DA022412 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI NUNES, EDWARD V. · 2007 to 2016
$1.7M
NIDA NIH HHS K24 DA022412NIDA NIH HHS K24 DA029647NIDA NIH HHS R01 DA010746NIDA NIH HHS T32 DA007294NIDA NIH HHS UG1 DA013035
6 · The paper itself

Abstract

objectiveThe oral formulation of the opioid antagonist naltrexone has shown limited effectiveness for treatment of opioid use disorder due to poor adherence. Long-acting injection naltrexone (XR-naltrexone), administered monthly, circumvents the need for daily pill taking, potentially improving adherence, and has been shown to be superior to placebo in reducing opioid use over 6 months of treatment. This open-label trial compared the outcomes of patients with opioid use disorder treated with XR-naltrexone or oral naltrexone in combination with behavioral therapy.

methodSixty opioid-dependent adults completed inpatient opioid withdrawal and were transitioned to oral naltrexone. They were stratified by severity of opioid use (six or fewer bags versus more than six bags of heroin per day) and randomly assigned (1:1) to continue treatment with oral naltrexone (N=32) or XR-naltrexone (N=28) for 24 weeks. The first dose of XR-naltrexone (380 mg) was administered prior to discharge, with monthly doses thereafter, and oral naltrexone was given in a 50-mg daily dose. All participants received weekly behavioral therapy to support treatment and adherence to naltrexone.

resultsA Cox proportional hazards model adjusting for race, gender, route of use, and baseline opioid use severity indicated that significantly more patients were retained in treatment for 6 months in the XR-naltrexone group (16 of 28 patients, 57.1%) than in the oral naltrexone group (nine of 32 patients, 28.1%) (hazard ratio=2.18, 95% CI=1.07, 4.43).

conclusionsPatients receiving XR-naltrexone had twice the rate of treatment retention at 6 months compared with those taking oral naltrexone. These results support the use of XR-naltrexone combined with behavioral therapy as an effective treatment for patients seeking opioid withdrawal and nonagonist treatment for preventing relapse to opioid use disorder.

Indexed as

Behavior TherapyAdministration, OralAdultDelayed-Action PreparationsFemaleHumansInjections, IntramuscularMaleMedication AdherenceMiddle AgedNaltrexoneNarcotic AntagonistsOpioid-Related DisordersRecurrenceTreatment OutcomeDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsvivitrolInjection NaltrexoneOpioid AntagonistOpioid Use DisorderOral NaltrexoneTreatment Retention

Identifiers

PMID30336703
PMCPMC6358483
OpenAlexW2897736788

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.