NALoxone InVEstigation (N-ALIVE) Pilot Randomised Controlled Trial (RCT)
| ISRCTN | ISRCTN34044390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34044390 |
| Secondary identifying numbers | MRC ref G0800012; MRC ID 85749; V1270808 |
- 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
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Pilot double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 At this point, the pilot study taking place in Scotland was withdrawn, and from this point the trial is taking place in England only.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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2010 |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 44 Years |
| Sex | Both |
| Target number of participants | 5,600 |
| 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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (UK)
Government
Government
20 Park Crescent
London
W1B 1AL
United Kingdom
| Website | http://www.mrc.ac.uk |
|---|---|
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (UK) (ref: G0800012; ID number 85749)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2013 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No |
Editorial Notes
14/11/2018: Publication references added.
