Trial reportContemporary clinical trials2015
Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial.
Trial report in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00781898 (Prevention of Relapse to Opioid Addiction Using Depot Naltrexone), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled 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.
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.
Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025Pooled it
- Interventions for female drug-using offenders.The Cochrane database of systematic reviews · 2019Pooled it
- Incidence of future arrests in adults involved in the criminal justice system with opioid use disorder receiving extended release naltrexone compared to treatment as usual.Drug and alcohol dependence · 2019Trial
- Do patient characteristics moderate the effect of extended-release naltrexone (XR-NTX) for opioid use disorder?Journal of substance abuse treatment · 2018Trial
- Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.Journal of substance abuse treatment · 2017Trial
- Cost-effectiveness of extended release naltrexone to prevent relapse among criminal justice-involved individuals with a history of opioid use disorder.Addiction (Abingdon, England) · 2017Trial
- Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.The New England journal of medicine · 2016Trial
- Identifying and Treating Incarcerated Women Experiencing Substance Use Disorders: A Review.Substance abuse and rehabilitation · 2023Review
- Opioid-specific medication-assisted therapy and its impact on criminal justice and overdose outcomes.Campbell systematic reviews · 2022Article
- Kentucky Women's Justice Community Opioid Innovation Network (JCOIN): A type 1 effectiveness-implementation hybrid trial to increase utilization of medications for opioid use disorder among justice-involved women.Journal of substance abuse treatment · 2021Article
- Adaptation of a standard extended-release naltrexone (XR-NTX) protocol for rural re-entering offenders with OUD.Health & justice · 2021Article
- Interventions for drug-using offenders with co-occurring mental health problems.The Cochrane database of systematic reviews · 2019Review
- Personal Control Over Decisions to Participate in Research by Persons With Histories of Both Substance Use Disorders and Criminal Justice Supervision.Journal of empirical research on human research ethics : JERHRE · 2018Article
- Relapse to opioid use disorder after inpatient treatment: Protective effect of injection naltrexone.Journal of substance abuse treatment · 2018Article
- Antagonist Models for Relapse Prevention and Reducing HIV Risk.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2016Review
- Safety and efficacy of high dose buprenorphine initiation in fentanyl positive emergency department patients.International journal of clinical trialsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundExtended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations.
methodsThis 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use.
resultsWe describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed.
conclusionsXR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898.
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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.