Evidence map›Paper›PMID 28940805›Full record

Trial reportDrug and alcohol review2018

Methods for delivering the UK's multi-centre prison-based naloxone-on-release pilot randomised trial (N-ALIVE): Europe's largest prison-based randomised controlled trial.

Angela Mary Meade, Sheila Macdonald Bird, John Strang, Tracey Pepple, Laura Lea Nichols, Monica Mascarenhas, Louise Choo, Mahesh Kumar Bhikhubhai Parmar

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug and alcohol review, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 15% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Interventions for female drug-using offenders.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Observational
  3. Article
  4. Article
  5. Observational
  6. Optimising opioid substitution therapy in the prison environment.International journal of prisoner health · 2019
    Article
  7. Review
  8. Article
  9. Article
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

8 authors at 3 institutions in 1 country.

Angela Mary MeadeMRC Clinical Trials Unit at University College London, London, UK.ORCID 0000-0001-6424-0554
Sheila Macdonald BirdMRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Cambridge, UK.
John StrangNational Addiction Centre, King's College London, London, UK.
Tracey PeppleMRC Clinical Trials Unit at University College London, London, UK.
Laura Lea NicholsMRC Clinical Trials Unit at University College London, London, UK.
Monica MascarenhasMRC Clinical Trials Unit at University College London, London, UK.
Louise ChooMRC Clinical Trials Unit at University College London, London, UK.
Mahesh Kumar Bhikhubhai ParmarMRC Clinical Trials Unit at University College London, London, UK.
MRC Clinical Trials Unit at UCL · GBKing's College London · GBUniversity of Cambridge · GB

Funding

Medical Research Council MC_U105260794Medical Research Council MC_UU_12023/30
6 · The paper itself

Abstract

INTRODUCTION AND

aimsNaloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin use by injection have a high risk of drug-related death in the first weeks after prison-release. The N-ALIVE trial was planned as a large prison-based randomised controlled trial (RCT) to test the effectiveness of naloxone-on-release in the prevention of fatal opiate overdoses soon after release. The N-ALIVE pilot trial was conducted to test the main trial's assumptions on recruitment of prisons and prisoners, and the logistics for ensuring that participants received their N-ALIVE pack on release. DESIGN AND

methodsAdult prisoners who had ever injected heroin, were incarcerated for ≥7 days and were expected to be released within 3 months were eligible. Participants were randomised to receive, on liberation, a pack containing a single 'rescue' injection of naloxone or a control pack with no naloxone syringe. The trial was double-blind prior to prison-release.

resultsWe randomised 1685 prisoners (842 naloxone; 843 control) across 16 prisons in England. We stopped randomisation on 8 December 2014 because only one-third of administrations of naloxone-on-release were to the randomised ex-prisoner; two-thirds were to others whom we were not tracing. DISCUSSION AND

conclusionsPrevention RCTs are seldom conducted within prisons; we demonstrated the feasibility of conducting a multi-prison RCT to prevent fatality from opioid overdose in the outside community. We terminated the N-ALIVE trial due to the infeasibility of individualised randomisation to naloxone-on-release. Large RCTs are feasible within prisons.

Indexed as

PrisonsAdultDouble-Blind MethodDrug OverdoseEnglandHumansNaloxoneNarcotic AntagonistsPilot ProjectsPrisonersResearch DesignNaloxoneNarcotic Antagonistsdrug-related deathN-ALIVEnaloxoneprison-releaserandomised

Identifiers

PMID28940805
PMCPMC5969312
OpenAlexW2799296988

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.