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

ISRCTN	ISRCTN34044390
DOI	https://doi.org/10.1186/ISRCTN34044390
Protocol serial number	MRC ref G0800012; MRC ID 85749; V1270808
Sponsor	Medical Research Council (UK)
Funder	Medical Research Council (UK) (ref: G0800012; ID number 85749)

Submission date: 30/09/2008
Registration date: 07/11/2008
Last edited: 14/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=80

Contact information

Prof Nicola Muirhead
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study design	Interventional
Study design	Pilot double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Naloxone-on-release pilot randomised controlled trial (RCT), in two prison systems and 5,600 eligible prisoners
Study acronym	N-ALIVE Pilot RCT
Study objectives	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 At this point, the pilot study taking place in Scotland was withdrawn, and from this point the trial is taking place in England only.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(s)	Essex 2 Research Ethics Committee on 18/05/2010
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Naloxone
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	44 Years
Sex	All
Target sample size at registration	5600
Key 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
Key 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
Date of first enrolment	01/12/2010
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2017		Yes	No
Results article	results	01/03/2017		Yes	No
Protocol article	protocol	01/10/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/11/2018: Publication references added.