Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC ref G0800012; MRC ID 85749; V1270808
Study information
Scientific title
Naloxone-on-release pilot randomised controlled trial (RCT), in two prison systems and 5,600 eligible prisoners
Acronym
N-ALIVE Pilot RCT
Study hypothesis
The hypothesis of the main trial is that giving naloxone on release to prisoners with a history of heroin use by injection will reduce heroin overdose deaths in this population by 28% in the first 12 weeks after release. The research questions addressed in this pilot study concern establishing whether prisons and eligible prisoners participate in the numbers expected and required in the main trial, field-testing the logistics of the main trial procedures, and obtaining qualitative data around post-release heroin use, overdoses witnessed or experienced, use of naloxone, and carriage of naloxone.
As of 08/10/2010 this record has been extensively updated. At this point, the pilot study taking place in Scotland was withdrawn, and from this point the trial is taking place in England only. The overall trial dates were also updated; the initial dates were as follows:
Initial overall trial start date: 01/04/2009
Initial overall trial end date: 31/03/2011
At this time, the target number of participants were also increased to 5600; the initial target number of participants was 5400.
Ethics approval
Essex 2 Research Ethics Committee on 18/05/2010
Study design
Pilot double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Heroin overdose deaths
Intervention
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 syringe and needle containing 2 miligrams Naloxone hydrochloride of which 800 micrograms should be given by IM injection in the event of heroin overdose.
Initial interventions at time of registration:
On randomisation, each participant is allocated a study number, which corresponds to a study pack held locally in the prison pharmacy. On release, the prisoner is issued with his/her pack. Treatment packs contain an information sheet (illustrating suitable IM injection sites), a pre-paid reply card, a carry pouch and the naloxone syringe (a single-use, safety-covered and pre-loaded syringe and needle containing 400 micrograms of naloxone hydrochloride) to be used in the event of heroin overdose. Control packs contain an information sheet (about the possible harm entailed by continuing heroin use), a pre-paid reply card, and a carry pouch, but no naloxone.
Participants who are randomised to the qualitative follow-up condition will be telephoned in either the first or second fortnight after release. Participants in Scotland will be asked to consent to completing a questionnaire if they return to prison within one year of release. Data concerning deaths and Accident and Emergency (A&E) admissions for non-fatal heroin overdoses will be accepted for up to 12 weeks after the release of each participant.
Intervention type
Drug
Phase
Not Applicable
Drug names
Naloxone
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/12/2010
Overall trial end date
31/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5,600
Participant 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
Recruitment start date
01/12/2010
Recruitment end date
31/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: G0800012; ID number 85749)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23633090