Evidence map›Paper›PMID 28358754›Full record

Trial reportJournal of addiction medicine

Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence.

Paul H Earley, Jacqueline Zummo, Asli Memisoglu, Bernard L Silverman, David R Gastfriend

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00834080 (Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT00834080 phase3completednot on this map

Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence

TypeinterventionalSponsorAlkermes, Inc.Ran2009 to 2012Enrolled38ConditionsOpiate DependenceArmsMedisorb naltrexone 380 mg
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  7. Observational
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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

5 authors at 1 institution in 1 country.

Paul H EarleyEarley Consultancy, LLC, Atlanta, GA (PHE); Alkermes, Inc, Waltham, MA (JZ, AM, BLS); Treatment Research Institute, Philadelphia, PA (DRG).
Jacqueline Zummo
Asli Memisoglu
Bernard L Silverman
David R Gastfriend
Brooklyn Law School · US

Funding

Novel, sustained-release naltrexone for opiate abuseR43DA013531 · NIDA · ALKERMES, INC. · PI BARTUS, RAYMOND T. · 2001 to 2001
$99k
NIDA NIH HHS R43 DA013531
6 · The paper itself

Abstract

objectivesHealthcare professionals (HCPs) with opioid dependence are at risk for relapse and death, particularly in the first year of recovery; however, maintenance treatment with opioid agonists is controversial in this safety-sensitive group. We evaluated long-term safety, tolerability, and treatment outcomes of injectable, intramuscular, extended-release naltrexone (XR-NTX) in opioid-dependent HCPs.

methodsThis single-arm, multisite, open-label study was conducted in opioid-dependent HCPs who had been detoxified from opioids for at least 2 weeks. Subjects received monthly XR-NTX injections for up to 24 months, combined with counseling via intensive outpatient substance abuse treatment programs. Assessments included monthly urine opioid drug tests and routine safety assessments, along with a trimonthly short form (36) Health Survey, opioid craving questionnaire, and Treatment Satisfaction Questionnaire for Medication.

resultsOf 49 opioid-dependent HCPs screened, 38 enrolled and received at least 1 XR-NTX injection. Most were female (n = 31) and nurses or nursing assistants (n = 30). More than half (n = 21; 55.3%) received at least 12 injections. Seven discontinued due to adverse events (3 anxiety, 2 headache, 1 injection-site mass, 1 derealization). None experienced relapses to opioid dependence necessitating detoxification, overdose, or death during treatment. At 24 months, mean opioid craving fell by 45.2%, and short form (36) mental component scores improved by 31.1% from baseline and approached normal levels. Of 22 unemployed subjects at baseline, 45.5% improved employment status at 24 months.

conclusionsLong-term (2 years) XR-NTX was associated with no new safety concerns, and, compared with shorter-term studies in the general population, similar or better rates of retention, opioid-negative urines, opioid craving reduction, mental health functional quality of life improvement, and re-employment.

Indexed as

Health PersonnelAdultDelayed-Action PreparationsDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, IntramuscularMaleMiddle AgedNaltrexoneNarcotic AntagonistsOccupational DiseasesOpioid-Related DisordersProspective StudiesTreatment OutcomeDelayed-Action PreparationsNaltrexoneNarcotic Antagonists

Identifiers

PMID28358754
PMCPMC5457834
OpenAlexW2601289664

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.