Evidence map›Paper›PMID 28068780›Full record

Trial reportThe American journal of psychiatry2017

Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.

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

2 registry-linked trialsOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of psychiatry, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 50 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 4 pooled it
13.6field-weighted citation impact, top 1% 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.

NCT03678792 phase3withdrawnnot on this mapstarted 2019, after this paper: background citation

Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2019 to 2020Enrolled0ConditionsOpioid-Related Disorders, Opioid WithdrawalArmsBuprenorphine/naloxone, Morphine, Tramadol
NCT04762537 nacompletednot on this mapstarted 2021, after this paper: background citation

Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone: Improving the Real-World Effectiveness of Injection Naltrexone for Opioid Use Disorder (SWIFT)

TypeinterventionalSponsorNew York State Psychiatric InstituteRan2021 to 2022Enrolled415ConditionsOpioid-use DisorderArmsStandard Induction Procedure (SP), Rapid Induction Procedure (RP)
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 4 syntheses or guidelines pooled it, 97 citations in OpenAlex.

  1. Pooled it
  2. Pharmacological therapies for management of opium withdrawal.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Opioid antagonists with minimal sedation for opioid withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Buprenorphine for managing opioid withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
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  11. Extended-release naltrexone for youth with opioid use disorder.Journal of substance abuse treatment · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Maria SullivanFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Adam BisagaFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Martina PavlicovaFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
C Jean ChoiFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Kaitlyn MishlenFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Kenneth M CarpenterFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Frances R LevinFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Elias DakwarFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
John J MarianiFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
Edward V NunesFrom the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.
New York Psychoanalytic Society and Institute · US

Funding

Improved Strategies for Outpatient Opioid DetoxificationR01DA030484 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI BISAGA, ADAM · 2011 to 2015
$3.1M
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 DA030484
6 · The paper itself

Abstract

objectiveAt present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection naltrexone (XR-naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-naltrexone.

methodParticipants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-naltrexone, consistent with official prescribing information for XR-naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-naltrexone.

resultsCompared with participants in the buprenorphine-assisted detoxification condition, participants assigned to naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline.

conclusionsThese results demonstrate the safety, efficacy, and tolerability of low-dose naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.

Indexed as

Ambulatory CareAdministration, OralAdolescentAdultBehavior TherapyBuprenorphineClonidineCombined Modality TherapyDelayed-Action PreparationsDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHumansInjections, IntramuscularMaleMiddle AgedBuprenorphineClonidineDelayed-Action PreparationsNaltrexoneBuprenorphineDetoxificationInjectable NaltrexoneNaltrexoneOpioid DependenceOutpatient

Identifiers

PMID28068780
PMCPMC5411308
OpenAlexW2570948865

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.