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

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.