title: Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.
abstract: 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 NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England.
  
  
  
  Parallel-group randomized controlled pilot trial.
  
  
  
  English prisons.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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%).
  
  
  
  Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014.
  
  
  
  Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population.
authors: MRC Clinical Trials Unit at University College London, London, UK.
authors: Mahesh K B
authors: MK
authors: Parmar
authors: National Addiction Centre at King's College London, London, UK.
authors: John
authors: J
authors: Strang
authors: MRC Clinical Trials Unit at University College London, London, UK.
authors: Louise
authors: L
authors: Choo
authors: MRC Clinical Trials Unit at University College London, London, UK.
authors: Angela M
authors: AM
authors: Meade
authors: MRC Biostatistics Unit, University of Cambridge Institute of Public Health, Cambridge, UK.
authors: Sheila M
authors: SM
authors: Bird
mesh_terms: D000293:Adolescent; D000328:Adult; D062787:Drug Overdose / Q000401:mortality / Q000517:prevention & control*; D004739:England / Q000453:epidemiology; D005260:Female; D006556:Heroin Dependence / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D010865:Pilot Projects; D011329:Prisoners / Q000706:statistics & numerical data*; D055815:Young Adult
chemical_list: D009292:Narcotic Antagonists; D009270:Naloxone
keywords: Fatality; naloxone; opioid-overdose; post-release; prevention; prisoners; randomization; trial