A randomised trial of effective and cost effectiveness of supervised versus unsupervised administration of buprenorphine-naloxone for heroin dependence

Intervention is sublingual bupernorphine-naloxone dispensed weekly i.e. not administered daily under supervision, weekly case management and monthly medical review. The duration of the randomised intervention is 3 months. At 3 months participants randomised to daily supervised administration who are clinically assessed as stable are transferred to weekly dispensed medication for a further 3 months. Similarly, those randomised to weekly dispensed medication who are clinically assessed as not being stable are transferred to weekly supervised administration for a further 3 months. Criteria for assessing stability is: 1. No evidence of unstable drug use, as defined by: a) Use of heroin, amphetamines and or cocaine on >4 occasions per month b) Daily average alcohol intake >60g alcohol c) Episodic or regular intoxication with benzodiazepines These are assessed by self-report, clinical examination, record of presentations intoxicated, and urine drug screening. 2. No risk factors for safety as evidenced by: a) Unstable accommodation and living arrangements (for example, partners /flatmates who are actively injecting, unsatisfactory storage facilities) b) Medical or psychiatric instability (assessed moderate risk of self-harm [depression with suicidal ideation], psychosis, decompensated liver disease, cognitive impairment which might make unsupervised medication unsafe) c) Children < 4 about whom there is DOCS involvement regarding parenting and in whom high levels of supervision and monitoring are thought to be in the child’s interest 3. Any evidence of diversion Dose is individually determined i.e. in keeping with usual care dosage is titrated for each patient. Please note the study factor is unsupervised administration i.e. the mode of administration not the medication or dosage itself.