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Randomized Controlled Trial
. 2017 Mar;112(3):502-515.
doi: 10.1111/add.13668. Epub 2016 Dec 13.

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

Mahesh K B Parmar  1 , John Strang  2 , Louise Choo  1 , Angela M Meade  1 , Sheila M Bird  3
Affiliations
Randomized Controlled Trial

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

Mahesh K B Parmar et al. Addiction. 2017 Mar.

Abstract

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 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.

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% 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.

Conclusions: 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.

Keywords: Fatality; naloxone; opioid-overdose; post-release; prevention; prisoners; randomization; trial.

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Figures

Figure 1
Figure 1
NALoxone InVEstigation (N‐ALIVE) pilot trial design and outcome measures. A full list of the trial's outcome measures is described in the N‐ALIVE protocol, which is available on the N‐ALIVE webpage: http://www.ctu.mrc.ac.uk/13391/13399/18277/n‐alive_trial_protocol
Figure 2
Figure 2
Consolidated Standards Of Reporting Trials (CONSORT) Diagram for the NALoxone InVEstigation (N‐ALIVE) pilot Trial. Screening records have been kept only since September 2012 to provide a snapshot of the proportions deemed eligible and subsequently randomized. *Excluded from intention‐to‐treat (ITT) analysis participants released after recruitment closure (n = 48, 40). **Included in per‐protocol (PP) analysis participants released with pack only
Figure 3
Figure 3
Explanation of the decision by the NALoxone InVEstigation (N‐ALIVE) Trial Steering—Data Monitoring Committee (TS‐DMC) to cease randomization in the N‐ALIVE pilot trial
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