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

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. CONDITION: Heroin overdose deaths ; Injury, Occupational Diseases, Poisoning ; Poisoning by narcotics and psychodysleptics [hallucinogens] PRIMARY OUTCOME: 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: 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 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