Condition category
Mental and Behavioural Disorders
Date applied
23/01/2008
Date assigned
05/02/2008
Last edited
28/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Holland

ORCID ID

Contact details

School of Medicine
Health Policy & Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 593574
r.holland@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

Super-C

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.

Ethics approval

Ethics approval received from the Hertfordshire Research Ethics Committee, 11/01/2008, ref: 07/H0311/198

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Buprenorphine, methadone

Primary outcome measures

Retention in treatment at three months.

Secondary outcome measures

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)

Overall trial start date

01/03/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

256

Participant 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)

Recruitment start date

01/03/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Hertfordshire Partnership NHS Foundation Trust (UK)

Sponsor details

R&D Office
Department of Psychiatry
QEII Hospital
Howlands
Welwyn Garden City
AL7 4HQ
United Kingdom

Sponsor type

Government

Website

http://www.hertsparts.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (UK) - Research for Patient Benefit Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24256157
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24304349

Publication citations

  1. Results

    Notley C, Holland R, Maskrey V, Nagar J, Kouimtsidis C, Regaining control: the patient experience of supervised compared with unsupervised consumption in opiate substitution treatment., Drug Alcohol Rev, 2014, 33, 1, 64-70, doi: 10.1111/dar.12079.

  2. Results

    Holland R, Maskrey V, Swift L, Notley C, Robinson A, Nagar J, Gale T, Kouimtsidis C, Treatment retention, drug use and social functioning outcomes in those receiving 3 months versus 1 month of supervised opioid maintenance treatment. Results from the Super C randomized controlled trial., Addiction, 2014, 109, 4, 596-607, doi: 10.1111/add.12439.

Additional files

Editorial Notes