The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project): a randomised controlled trial comparing the effects of differing therapeutic agents for detoxification from either street heroin or methadone
| ISRCTN | ISRCTN07752728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07752728 |
| Secondary identifying numbers | None |
- Submission date
- 29/05/2002
- Registration date
- 29/05/2002
- Last edited
- 05/01/2011
- 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 Nat Wright
Scientific
Scientific
NFA Health Centre for Homeless People
68 York Street
Leeds
LS9 8AA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | LEEDS project |
| Study objectives | The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. |
| Ethics approval(s) | Approval for the trial has been granted from the NHS Local Research Ethics Committee based at Saint James's University Hospital, Leeds. |
| Health condition(s) or problem(s) studied | Participants are taking street opiates or street methadone |
| Intervention | A randomised controlled trial will be implemented using buprenorphine sublingual tablets or dihydrocodenine. Prescriptions for either of the two therapeutic agents will be randomly assigned to participants over a two week treatment programme. A urine sample will be taken on the day the final prescription is written to determine abstinence of opiates. Follow up studies will be conducted at three and six month stages where a brief questionnaire will be asked. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Buprenorphine, dihydrocodeine |
| Primary outcome measure | Abstinence from street opiates at receiving the final prescription, indicated by a urine test free of illicit opiates or their metabolites. |
| Secondary outcome measures | 1. Significant adverse effects 2. Inappropriate use of prescribed medication (e.g. intentional overdose) 3. Presentation at Accident and Emergency Departments 4. Admission to hospital |
| Overall study start date | 01/03/2002 |
| Completion date | 01/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Above the age of 18 years 2. Using moderate levels of street opiates or taking street methadone 3. Have expressed a wish to detoxify from either street heroin or methadone through a standard monitored process 4. Participants must be registered at one of the practices taking part in the LEEDS project |
| Key exclusion criteria | Does not comply with above inclusion criteria |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NFA Health Centre for Homeless People
Leeds
LS9 8AA
United Kingdom
LS9 8AA
United Kingdom
Sponsor information
NFA Health Centre for Homeless People (UK)
Hospital/treatment centre
Hospital/treatment centre
68 York Street
Leeds
LS9 8AA
England
United Kingdom
Funders
Funder type
Government
North East Primary Care Trust (formerly Leeds Health Authority) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol for open-label pragmatic randomised control trial | 29/04/2004 | Yes | No | |
| Protocol article | protocol for pilot study of randomised controlled trial | 08/01/2007 | Yes | No | |
| Results article | results | 05/02/2009 | Yes | No |
