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ISRCTN
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ISRCTN07752728
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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LEEDS project
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Serial number at source
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None
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Study hypothesis
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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.
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Ethics approval
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Approval for the trial has been granted from the NHS Local Research Ethics Committee based at Saint James's University Hospital, Leeds.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Participants are taking street opiates or street methadone
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Does not comply with above inclusion criteria
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Anticipated start date
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01/03/2002
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Anticipated end date
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01/03/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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120
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Interventions
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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.
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Primary outcome measure(s)
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Abstinence from street opiates at receiving the final prescription, indicated by a urine test free of illicit opiates or their metabolites.
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Secondary outcome measure(s)
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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
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Sources of funding
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North East Primary Care Trust (formerly Leeds Health Authority) (UK)
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Trial website
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Publications
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Study protocol:
1. http://www.ncbi.nlm.nih.gov/pubmed/15117415
2. http://www.ncbi.nlm.nih.gov/pubmed/17210080
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Contact name
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Dr
Nat
Wright
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Address
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NFA Health Centre for Homeless People
68 York Street
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City/town
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Leeds
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Zip/Postcode
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LS9 8AA
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Country
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United Kingdom
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Sponsor
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NFA Health Centre for Homeless People (UK)
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Address
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68 York Street
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City/town
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Leeds
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Zip/Postcode
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LS9 8AA
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Country
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United Kingdom
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Date applied
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29/05/2002
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Last edited
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07/03/2008
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Date ISRCTN assigned
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29/05/2002
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