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

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Pilot Study will use randomised controlled trial methodology to compare the open use of buprenorphine and dihydrocodeine for opiate detoxification, given in the context of routine care, within HMP Leeds. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome measure will be abstinence status at five days post detoxification, as determined by a urine test. Secondary outcomes during the detoxification and then at one, three and six months post detoxification will be recorded.In the United Kingdom (U.K), there is an extensive market for the sale of heroin, an illicit class 'A' drug. Precise figures of how many people use and are dependent on heroin are difficult to establish as there has never been a national prevalence survey [1]. The link between crime and illicit drug use, specifically heroin use, is well recognised. In 2002, 63% of injecting drug users (IDUs) in contact with specialist drugs services in England and Wales reported having ever been in prison or a young offenders' institution [2]. Those addicted to illicit opiates such as heroin require medical help in reducing and stopping their use due to the drug's highly addictive properties.Neither the current evidence base [1] nor the national guidelines on the clinical management of drug misuse [3] stipulate a 'drug of choice' for rapid opiate detoxification. In the absence of an established evidence base, a wide variety of agents have therefore been used including methadone, dihydrocodeine, buprenorphine, lofexidine and clonidine. Historically within prisons, the most commonly used drug for opiate detoxification has been dihydrocodeine. Anecdotally this was because of a reluctance to prescribe methadone following a small number of methadone related deaths in the prison setting. Dihydrocodeine is attractive to clinicians as it has a shorter half-life than methadone, and seems equally accept