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NALoxone InVEstigation (N-ALIVE) Pilot Randomised Controlled Trial (RCT)

Naloxone-on-release pilot randomised controlled trial (RCT), in two prison systems and 5,600 eligible prisoners

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34044390
Enrollment
5600
Registered
2008-11-07
Start date
2010-12-01
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin overdose deaths Injury, Occupational Diseases, Poisoning Poisoning by narcotics and psychodysleptics [hallucinogens]

Interventions

Amended as of 08/10/2010: Participants randomised to the treatment arm of the study will be given a pack on release from prison containing a single-use, safety-covered and pre-loaded s

Sponsors

Medical Research Council (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females, 18-44 years old at randomisation date 2. Incarceration begun at least seven days before randomisation date 3. History of heroin use by injection 4. Likely release date within three months of randomisation date 5. Has not been randomised in N-ALIVE and then withdrawn consent prior to release from prison

Exclusion criteria

Exclusion criteria: 1. History of adverse reaction to naloxone 2. Non-resident in England, Wales or Scotland 3. Most recent index release date is within six months of randomisation date 4. Index release date is missing and participant was previously randomised in N-ALIVE in the past year 5. Participant withdraws consent prior to release 6. Participant dies prior to release 7. Exclusion from qualitative follow-up if randomised to 'No qualitative follow-up' 8. Exclusion from qualitative follow up if randomised to 'Qualitative follow-up' but participant does not consent to this part of the pilot

Design outcomes

Primary

MeasureTime frame
1. Numbers of participating prisons and eligible prisoners 2. Number of participants contacted in qualitative follow-up 3. Questionnaire data concerning post-release heroin use, naloxone carriage and use, overdoses witnessed and experienced Added 08/10/2010: 4. Numbers of heroin overdose deaths among participants in both arms of the pilot study Qualitative data will be measured at either the first two or four weeks post-release, or up to one year after release in the case of questionnaires in Scotland. Data concerning rates of participation will be monitored throughout the study's two-year duration.

Secondary

MeasureTime frame
Amended as of 08/10/2010: The following will be measured at 12 weeks post-release: numbers of non-fatal A&E admissions among participants in both arms of the pilot study Initial information at time of registration: The following will be measured at 12 weeks post-release: 1. Numbers of heroin overdose deaths among participants in both arms of the pilot study 2. Numbers of non-fatal A&E admissions among participants in both arms of the pilot study

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026