Study protocol

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

Laura Sheard¹ , Nat MJ Wright¹ , Clive E Adams² , Nicole Bound³ , Bruno Rushforth³ , Roger Hart³ and Charlotte NE Tompkins¹

¹  Leeds Primary Care Trust based at Leeds Institute for Health Sciences, 101 Clarendon Road, Leeds, LS2 9LJ, UK

²  Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK

³  Formerly HMP Leeds, 2 Gloucester Terrace, Armley, Leeds, LS12 2TJ, UK

author email corresponding author email

Trials 2009, 10:53doi:10.1186/1745-6215-10-53

Published:	14 July 2009

Abstract

Background

In the United Kingdom (UK), there is an extensive market for the class 'A' drug heroin and many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to cease their drug use. The most commonly used detoxification agents in UK prisons are currently buprenorphine and methadone, both are recommended by national clinical guidelines. However, these agents have never been compared for opiate detoxification in the prison estate and there is a general paucity of research evaluating the most effective treatment for opiate detoxification in prisons. This study seeks to address this paucity by evaluating the most routinely used interventions amongst drug users within UK prisons.

Methods/Design

This study uses randomised controlled trial methodology to compare the open use of buprenorphine and methadone for opiate detoxification, given in the context of routine care, within three UK prisons. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome will be abstinence status eight days after detoxification, as determined by a urine test. Secondary outcomes will be recorded during the detoxification and then at one, three and six months post-detoxification.

Trial registration

Current Controlled Trials ISRCTN58823759