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Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.
- Source :
- Addiction; Mar2017, Vol. 112 Issue 3, p502-515, 14p, 2 Diagrams, 5 Charts
- Publication Year :
- 2017
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- NALOXONE
DRUG overdose
FORMERLY incarcerated people
DRUG abuse prevention
OPIOID abuse
RESUSCITATION
PEOPLE with heroin addiction
AT-risk people
RANDOMIZED controlled trials
SUBSTANCE abuse
EQUIPMENT & supplies
PREVENTION
DEATH
CHI-squared test
CONFIDENCE intervals
CORRECTIONAL institutions
CRIMINALS
FISHER exact test
HEROIN
INFORMED consent (Medical law)
PRISONERS
QUESTIONNAIRES
RESEARCH funding
RISK assessment
PILOT projects
HUMAN research subjects
BLIND experiment
DESCRIPTIVE statistics
Subjects
Details
- Language :
- English
- ISSN :
- 09652140
- Volume :
- 112
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Addiction
- Publication Type :
- Academic Journal
- Accession number :
- 121147713
- Full Text :
- https://doi.org/10.1111/add.13668