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

TY - JOUR

T1 - Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths

AU - Parmar, Mahesh K B

AU - Strang, John

AU - Choo, Louise

AU - Meade, Angela M

AU - Bird, Sheila M

N1 - This article is protected by copyright. All rights reserved.

PY - 2016/10/24

Y1 - 2016/10/24

N2 - 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.

AB - 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.

U2 - 10.1111/add.13668

DO - 10.1111/add.13668

M3 - Article

C2 - 27776382

SN - 0965-2140

JO - Addiction

JF - Addiction

ER -