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| A randomised controlled trial, economic evaluation and qualitative study of supervised consumption in patients managed with opiate maintenance treatment (the Super-C study) |
| Source of record | UK Trials |
| ISRCTN | ISRCTN61294249 |
| Date ISRCTN assigned | 05/02/2008 |
| Local reference number(s) | 1 |
| Public title | A randomised controlled trial, economic evaluation and qualitative study of supervised consumption in patients managed with opiate maintenance treatment (the Super-C study) |
| Scientific title | |
| Acronym | Super-C |
| Disease/condition/study domain | Substance misuse - opiate dependance |
| Study hypothesis | Null hypothesis: that there is no difference in proportion of patients retained in treatment over three months between those supervised (intervention) and those receiving unsupervised consumption (control) of opiate maintenance therapy. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval received from the Hertfordshire Research Ethics Committee on the 11th January 2008 (ref: 07/H0311/198). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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) |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Target number of participants | 256 |
| 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). 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. |
| Primary outcome measure(s) | Retention in treatment at three months. |
| Secondary outcome measure(s) | 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) |
| Sources of funding | National Institute of Health Research (UK) - Research for Patient Benefit Programme |
| Sponsor name | Hertfordshire Partnership NHS Foundation Trust (UK) |
| Sponsor details | R&D Office Department of Psychiatry QEII Hospital, Howlands Welwyn Garden City United Kingdom AL7 4HQ |
| Sponsor website | http://www.hertsparts.nhs.uk/ |
| Contact name | Dr Richard Holland |
| Contact details | School of Medicine, Health Policy & Practice University of East Anglia Norwich United Kingdom NR4 7TJ |
| Contact telephone | +44 (0)1603 593574 |
| Contact fax | +44 (0)1603 593752 |
| Contact email | r.holland@uea.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61294249 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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