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.

Autor: Meade AM; MRC Clinical Trials Unit at University College London, London, UK., Bird SM; MRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Cambridge, UK., Strang J; National Addiction Centre, King's College London, London, UK., Pepple T; MRC Clinical Trials Unit at University College London, London, UK., Nichols LL; MRC Clinical Trials Unit at University College London, London, UK., Mascarenhas M; MRC Clinical Trials Unit at University College London, London, UK., Choo L; MRC Clinical Trials Unit at University College London, London, UK., Parmar MKB; MRC Clinical Trials Unit at University College London, London, UK.
Jazyk: angličtina
Zdroj: Drug and alcohol review [Drug Alcohol Rev] 2018 May; Vol. 37 (4), pp. 487-498. Date of Electronic Publication: 2017 Sep 21.
DOI: 10.1111/dar.12592
Abstrakt: Introduction and Aims: Naloxone 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 Methods: Adult 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.
Results: We 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 Conclusions: Prevention 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.
(© 2017 The Authors Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)
Databáze: MEDLINE
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