Evidence map›Paper›PMID 25555621›Full record

Trial reportDrug and alcohol dependence2015

Opioid use and dropout in patients receiving oral naltrexone with or without single administration of injection naltrexone.

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

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  4. Trial
  5. Trial
  6. Review
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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 3 institutions in 1 country.

Maria A SullivanColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: mas23@columbia.edu.
Adam BisagaColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: amb107@columbia.edu.
Andrew GlassColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: glassan@nyspi.columbia.edu.
Kaitlyn MishlenColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: mishlen@nyspi.columbia.edu.
Martina PavlicovaColumbia University, 722 W. 168th Street, MSPH Box 12, New York, NY 10032, United States. Electronic address: mp2370@columbia.edu.
Kenneth M CarpenterColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: carpent@nyspi.columbia.edu.
John J MarianiColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: mariani@nyspi.columbia.edu.
Frances R LevinColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: Frl2@columbia.edu.
Edward V NunesColumbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: nunesed@nyspi.columbia.edu.
Columbia University · USNew York State Psychiatric InstituteNew York Psychoanalytic Society and Institute · US

Funding

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 DA010746
6 · The paper itself

Abstract

backgroundAdherence to oral naltrexone has been poor and can be improved somewhat with behavioral therapy. We compared behavioral naltrexone therapy (BNT) to compliance enhancement (CE) and tested efficacy of single-dose injection naltrexone (XR-NTX; 384 mg) with behavioral therapies at further improving adherence to oral naltrexone.

methodsA 24-week, randomized, placebo-controlled trial (n=125) compared four treatment conditions following inpatient detoxification and oral naltrexone induction: (1) BNT+XR-NTX; (2) BNT+placebo injection; (3) CE+XR-NTX; and (4) CE+placebo injection. All participants were maintained on oral naltrexone throughout the trial. Primary outcome was retention in treatment.

resultsOf 89 randomized participants, 78.7% (70/89) completed 4 weeks, 58.2% (54/89) completed 8 weeks, 47.2% (42/89) completed 12 weeks, and 25.8% (23/89) completed 24 weeks. A Cox proportional hazards regression modeled time to dropout as a function of treatment condition, baseline opioid dependence severity (bags per day of heroin use), and their interaction. Interaction of conditions by baseline severity was significant (X3(2)=9.19, p=0.027). For low-severity patients (≤ 6 bags/day), retention was highest in the BNT-XR-NTX group (60% at 6 months), as hypothesized. For high-severity (>6 bags/day) patients, BNT-XR-NTX did not perform as well, due to high early attrition.

conclusionFor low-severity heroin users, single-dose XR-NTX improved long-term treatment retention when combined with behavioral therapy. In higher-severity opioid-dependent patients, XR-NTX was less helpful, perhaps because, combined with oral naltrexone, it produced higher blood levels and more withdrawal discomfort. When cost considerations recommend oral naltrexone following XR-NTX, the latter should be phased in slowly.

Indexed as

Behavior TherapyPatient DropoutsAdministration, OralAdultDelayed-Action PreparationsFemaleFollow-Up StudiesHumansInjections, IntravenousMaleMiddle AgedNaltrexoneNarcotic AntagonistsOpioid-Related DisordersPatient ComplianceDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsInjection naltrexoneOpiate dependence treatmentOpioid antagonistOral naltrexonePharmacotherapy trials

Identifiers

PMID25555621
PMCPMC4435949
OpenAlexW2053509760

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.