A randomised controlled trial, economic evaluation and qualitative study of supervised consumption in patients managed with opiate maintenance treatment (the Super-C study)

INTERVENTION: The intervention group will be supervised (i.e. observed by their dispensing pharmacist) consuming whichever opiate replacement drug that they have been prescribed (either methadone or buprenorphine). This intervention will occur daily (6 ‐ 7 days/week) and will continue for three months. The control group will be dispensed their opiate replacement drug (methadone or buprenorphine) on a daily basis (6 ‐ 7 days per week). Their consumption of this will be supervised for the first week. After that they will be able to consume their medication in private (i.e. unsupervised). Please note the choice of opiate maintenance therapy (methadone or buprenorphine) and dose of drug used for each participant, is a clinical decision and does not form part of this study (though it will be recorded in each case). Follow‐up will continue for six months. CONDITION: Substance misuse ‐ opiate dependance ; Mental and Behavioural Disorders ; Opiate dependance PRIMARY OUTCOME: Retention in treatment at three months. SECONDARY OUTCOME: 1. Retention in treatment at six months (from clinic records); ; All others measured at 3 months only, through follow‐up interview, data from keyworkers (Christo score) or clinic records/routine data:; 2. Evidence of reduction in use of illicit opioids (urine testing and Maudsley addiction profile results [MAP]); 3. Use of other illicit drugs and alcohol use (urine testing results from clinic records and MAP results) ; 4. Addiction severity and social functioning (measured by Christo score ‐ provided by keyworkers) ; 5. Changes in psychological functioning (measured by the MAP); 6. Changes in quality of life measured by the 12‐item short form health survey (SF‐12) and the capability index (self‐complete questionnaires) ; 7. Changes in criminal behaviour (MAP) ; 8. Adverse events (emergency hospital attendance [accidency and emergency department attendance or hospital admission] with symptoms of drug overdose/death); 9. Average dose of drug prescribed over treatment period (clinic records); 10. Self‐report satisfaction with pharmacy (3‐month follow‐up drug use questionnaire); 11. Self‐report drug compliance and diversion (3‐month follow‐up drug use questionnaire); 12. Monthly assessment of injecting sites for those injecting at baseline (clinic records); 13. Treatment outcomes profile (clinic records using National Treatment Agency form which is collected routinely by drug service) INCLUSION CRITERIA: 1. Confirmed symptoms of opioid dependency (including toxicological investigations) 2. Electing for maintenance treatment (as opposed to other forms of management, e.g., detoxification) with either methadone or buprenorphine 3. Aged 16 years or older, either sex