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Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths

Parmar, MK; Strang, J; Choo, L; Meade, AM; Bird, SM; (2017) Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths. Addiction , 112 (3) pp. 502-515. 10.1111/add.13668. Green open access

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Abstract

BACKGROUND AND AIMS: Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The N-ALIVE pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. DESIGN: Parallel group randomized controlled pilot trial. SETTING: English prisons. PARTICIPANTS: A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. INTERVENTION: Using 1:1 minimization, prisoners were randomized to receive on-release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. MEASUREMENTS: Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4-weeks) and overdose-presence (80%). FINDINGS: Prisons (16) and prisoners (1685) were willing to participate (consent-rate, 95% CI: 70% to 74%); 218 RPSQs were received; NOR-carriage (95% CI: 63% to 79%) and overdose-presence (95% CI: 75% to 84%) were as expected. We randomized 842 to NOR, 843 to control during 30 months but stopped early because only one third of NOR administrations was to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. CONCLUSION: Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measures to prevent heroin overdose deaths among ex-prisoners and the wider population.

Type: Article
Title: Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1111/add.13668
Publisher version: http://doi.org/10.1111/add.13668
Language: English
Additional information: Copyright © 2016 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/1527493
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