Condition category
Mental and Behavioural Disorders
Date applied
16/08/2005
Date assigned
15/09/2005
Last edited
22/05/2012
Prospective/Retrospective
Prospectively 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

Prof Clive Adams

ORCID ID

Contact details

Dept. of Psychiatry
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

Acronym

LEEDS

Study hypothesis

To evaluate whether buprenorphine or methadone given openly to illicit opiate users presenting for detoxification in the UK NHS prison setting helps achieve abstinence at completion of regime

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Problematic use of illicit opiates requiring medical detoxification

Intervention

Buprenorphine or methadone

Intervention type

Drug

Phase

Not Specified

Drug names

Buprenorphine and methadone

Primary outcome measures

Abstinence of illicit opiates 5 days post completion of detoxification as indicated by a urine test

Secondary outcome measures

Adverse events recorded during the detoxification period: inappropriate use of prescribed medication, overdose, admission to prison healthcare, accident and emergency (A&E) or hospital. Abstinence at 1, 3 and 6 months post detoxification. At 1, 3 and 6 months: evidence and volume of service utilisation.

Overall trial start date

01/11/2005

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Male or female, 18-65 years old, using illicit opiates as confirmed by a urine test at first assessment, remaining in the prison estate for longer than 28 days

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

340

Participant exclusion criteria

Contraindications to buprenorphine or methadone,
co-existing acute medical conditions requiring emergency admission to hospital so precluding detoxification in the prison setting, currently undergoing detoxification from other addictive drugs whereby concurrent detoxification from illicit opiates would not be clinically indicated, women who are pregnant or breastfeeding, prisoners previously randomised into this trial

Recruitment start date

01/11/2005

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept. of Psychiatry
Leeds
LS2 9LT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

School of Medicine
24 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Department of Health Forensic Mental Health Research Funding Scheme 2004 (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

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19602218
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22137413

Publication citations

  1. Protocol

    Sheard L, Wright NM, Adams CE, Bound N, Rushforth B, Hart R, Tompkins CN, The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project Study: protocol for a randomised controlled trial comparing methadone and buprenorphine for opiate detoxification., Trials, 2009, 10, 53, doi: 10.1186/1745-6215-10-53.

  2. Results

    Wright NM, Sheard L, Adams CE, Rushforth BJ, Harrison W, Bound N, Hart R, Tompkins CN, Comparison of methadone and buprenorphine for opiate detoxification (LEEDS trial): a randomised controlled trial., Br J Gen Pract, 2011, 61, 593, e772-80, doi: 10.3399/bjgp11X613106.

Additional files

Editorial Notes