Abstract
Background and AimsNaloxone 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.Design.Parallel‐group randomized controlled pilot trial.SettingEnglish prisons.ParticipantsA 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.InterventionUsing 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.MeasurementsKey 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%).FindingsPrisons (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.ConclusionsLarge 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.
Highlights
Prisoners with a history of heroin injection have a high risk of drug-related death (DRD) soon after prison-release which was estimated at 5 DRDs per 1000 eligible releases on the basis of recordlinkage studies in Scotland in 1996-991, and in England and Wales in 1999-2002.2 See metaanalyses[3 4]
We report the key feasibility outcomes of the N-ALIVE pilot trial compared with prior expectations in the trial protocol (ISRCTN34044390)[18], as follows: i) Participation by prisons and prisoners; ii) Consents for randomization, Returned Prisoner Self-Questionnaire (RPSQ), phone-contact sub-study; iii) Receipt of returned prisoner selfquestionnaires (RPSQs); iv) NOR-carriage and overdose-presence; v) Whether the N-ALIVE main trial could go ahead as planned, including assessment of to whom NOR was administered
The N-ALIVE main trial was to investigate if NOR could reduce DRDs in the first 4 weeks after release by 30%, from 140 to 98 per 28,000 eligible releases; and in weeks 5-12 by 20%, from 35 to 28 per 28,000 eligible releases, for which randomization of 56,000 eligible releases would be needed for 80% power at 5% significance level
Summary
Prisoners with a history of heroin injection have a high risk of drug-related death (DRD) soon after prison-release which was estimated at 5 DRDs per 1000 eligible releases on the basis of recordlinkage studies in Scotland in 1996-991, and in England and Wales in 1999-2002.2 See metaanalyses[3 4].Naloxone is an opioid antagonist that can be administered intramuscularly and is used by emergency services to reverse heroin/opioid overdose[5]. Prisoners with a history of heroin injection have a high risk of drug-related death (DRD) soon after prison-release which was estimated at 5 DRDs per 1000 eligible releases on the basis of recordlinkage studies in Scotland in 1996-991, and in England and Wales in 1999-2002.2 See metaanalyses[3 4]. The feasibility of randomized provision of naloxone-onrelease (NOR) to a high-DRD-risk population, such as inmates with a history of heroin injection use on their release from prison as proposed by Bird and Hutchinson[1], had not been investigated. 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
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