Condition category
Mental and Behavioural Disorders
Date applied
29/05/2002
Date assigned
29/05/2002
Last edited
05/01/2011
Prospective/Retrospective
Retrospectively 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 Nat Wright

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

None

Study information

Scientific title

Acronym

LEEDS project

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Buprenorphine, dihydrocodeine

Primary outcome measures

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 trial start date

01/03/2002

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Does not comply with above inclusion criteria

Recruitment start date

01/03/2002

Recruitment end date

01/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

NFA Health Centre for Homeless People (UK)

Sponsor details

68 York Street
Leeds
LS9 8AA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

North East Primary Care Trust (formerly Leeds Health Authority) (UK)

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

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

Publication citations

  1. Protocol for pilot study of randomised controlled trial

    Sheard L, Adams CE, Wright NM, El-Sayeh H, Dalton R, Tompkins CN, The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) prisons project pilot study: protocol for a randomised controlled trial comparing dihydrocodeine and buprenorphine for opiate detoxification., Trials, 2007, 8, 1, doi: 10.1186/1745-6215-8-1.

  2. Results

    Sheard L, Wright NM, El-Sayeh HG, Adams CE, Li R, Tompkins CN, The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) prisons project: a randomised controlled trial comparing dihydrocodeine and buprenorphine for opiate detoxification., Subst Abuse Treat Prev Policy, 2009, 4, 1, doi: 10.1186/1747-597X-4-1.

  3. Oldham NS, Wright NM, Adams CE, Sheard L, Tompkins CN, The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project: an open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728]., BMC Fam Pract, 2004, 5, 9, doi: 10.1186/1471-2296-5-9.

Additional files

Editorial Notes