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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 10.1186/ISRCTN07752728
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym LEEDS project
Serial number at source None
Study hypothesis 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.
Lay summary
Ethics approval Approval for the trial has been granted from the NHS Local Research Ethics Committee based at Saint James's University Hospital, Leeds.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Participants are taking street opiates or street methadone
Participants - 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
Participants - exclusion criteria Does not comply with above inclusion criteria
Anticipated start date 01/03/2002
Anticipated end date 01/03/2005
Status of trial Completed
Patient information material
Target number of participants 120
Interventions 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.
Primary outcome measure(s) Abstinence from street opiates at receiving the final prescription, indicated by a urine test free of illicit opiates or their metabolites.
Secondary outcome measure(s) 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
Sources of funding North East Primary Care Trust (formerly Leeds Health Authority) (UK)
Trial website
Publications Study protocol:
2004 protocol for open-label pragmatic randomised control trial in http://www.ncbi.nlm.nih.gov/pubmed/15117415
2007 protocol for pilot study of randomised controlled trial in http://www.ncbi.nlm.nih.gov/pubmed/17210080
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19196468
Contact name Dr  Nat  Wright
  Address NFA Health Centre for Homeless People
68 York Street
  City/town Leeds
  Zip/Postcode LS9 8AA
  Country United Kingdom
Sponsor NFA Health Centre for Homeless People (UK)
  Address 68 York Street
  City/town Leeds
  Zip/Postcode LS9 8AA
  Country United Kingdom
Date applied 29/05/2002
Last edited 05/01/2011
Date ISRCTN assigned 29/05/2002
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