Substance misuse - opiate dependance Mental and Behavioural Disorders Opiate dependance
Conditions
Interventions
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).
Sponsors
Hertfordshire Partnership NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Chronic injectors refusing oral therapy 2. Under 16 years 3. Hypersensitivity to both buprenorphine and methadone 4. Treatment with suboxone (as this is not routinely supervised) 5. Severe medical condition making treatment hazardous in the opinion of the treating physician 6. Incapacity to give informed consent 7. Maintenance treatment during last four weeks 8. Those patients deemed to definitely require supervised consumption at discretion of the treating physician (such as homeless, those with a drug-using partner not in treatment) 9. Those patients where supervised consumption of their agreed treatment can not be provided for reasons of geographical placement (e.g. no provision of supervised consumption in the local pharmacy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention in treatment at three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed