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
Protocol serial number None
Sponsor NFA Health Centre for Homeless People (UK)
Funder North East Primary Care Trust (formerly Leeds Health Authority) (UK)
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

NFA Health Centre for Homeless People
68 York Street
Leeds
LS9 8AA
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymLEEDS project
Study objectivesThe 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) studiedParticipants are taking street opiates or street methadone
InterventionA 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 typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Buprenorphine, dihydrocodeine
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.

Key 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

Completion date01/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration120
Key inclusion criteria1. 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 criteriaDoes not comply with above inclusion criteria
Date of first enrolment01/03/2002
Date of final enrolment01/03/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

NFA Health Centre for Homeless People
Leeds
LS9 8AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/02/2009 Yes No
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
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