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

ISRCTN	ISRCTN61294249
DOI	https://doi.org/10.1186/ISRCTN61294249
Protocol serial number	1
Sponsor	Hertfordshire Partnership NHS Foundation Trust (UK)
Funder	National Institute of Health Research (UK) - Research for Patient Benefit Programme

Submission date: 23/01/2008
Registration date: 05/02/2008
Last edited: 28/04/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Holland
Scientific

School of Medicine, Health Policy & Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Phone	+44 (0)1603 593574
Email	r.holland@uea.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	Super-C
Study objectives	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.
Ethics approval(s)	Ethics approval received from the Hertfordshire Research Ethics Committee, 11/01/2008, ref: 07/H0311/198
Health condition(s) or problem(s) studied	Substance misuse - opiate dependance
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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Buprenorphine, methadone
Primary outcome measure(s)	Retention in treatment at three months.
Key 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)
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	256
Key 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
Key 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)
Date of first enrolment	01/03/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Medicine, Health Policy & Practice

Norwich
NR4 7TJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No
Results article	results	01/04/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes