Extrait

Background and study aims In the National Health Service (NHS) in England the front-line clinical intervention for heroin dependence is the prescription of opiate substitute medications: commonly methadone or suboxone (buprenorphine-naloxone) combined with clinical and keyworker case coordination [treatment as usual (TAU)]. The two substitution medications have been proven to be effective at reducing heroin use, overdose risk and lowering rates of acquisitive crime involvement. However, if there is use of cocaine in combination with heroin use it is less likely there will be a positive response to treatment. Whether or not there is cocaine use not all clients receiving the substitute medications experience a positive outcome. A minority will not be able to stop or will relapse into heroin use and will deteriorate progressively during treatment. Who can participate? Every patient who comes to Lorraine Hewitt House (LHH), an NHS treatment centre in London, UK for opiate substitution treatment over a two year period between October 2012 & September 2014 (study end date November 2015) will be asked to participate if they meet the participant selection criteria. What does the study involve? This study has three main aims: 1. In phase one to find out whether suboxone is more effective at achieving heroin and cocaine abstinence when compared to methadone; 2. In phase two to find out among those participants from the first phase who have not been able to stop using heroin and cocaine whether receiving a comprehensive weekly Personalised Behavioural Intervention (PBI) is more likely to result in them stopping using heroin and cocaine within 12 weeks compared to the standard clinical and keyworker case coordination (usually fortnightly) 3. To evaluate and compare the cost effectiveness of the different treatment configurations in the trial. At phase one the participants will be randomised to one of the substitution medications (subject to clinical review) or if they have a strong preference for one of the medications they will have the option to select their medication in consultation with the clinical team. All participants who continue into phase two will be randomised to either PBI or continued standard clinical and keyworker case coordination. The participants who do stop heroin & cocaine use by 12 week will as is routine at LHH move onto shared care treatment between the LHH clinical and keyworker team and the participant’s family doctor. A battery of drug use, health, social functioning, service usage and quality of life measures will be delivered across the 24 week participation period with the main measures repeated at week 1, week 12, and week 24. What are the possible benefits and risks of participating? The substitution medications and basic components of the PBI have all been used extensively in the treatment of opiate dependency. It has been assessed that the study participants will be at no greater risk than would occur in the standard treatment program. There are no confirmed direct benefits to participants. In addition to participating in the trial participants will also be given the option participating in two associated pieces of research: 1 To provide a cheek swab DNA sample for research into genetic factor links to treatment response, 2. To participate in a longer term study to find out what happens happen to participants in the study over the next 5 years. They will be asked to allow their personal details to be flagged on three public databases:National Drug Treatment Monitoring System (NDTMS); Police National Computer (PNC); NHS Registry of Births and Deaths (NHSCR). Where is the study run from? Lorraine Hewitt House (LHH), an NHS treatment centre in London, UK When is the study starting and how long is it expected to run for? The study started in October 2012 and will run until October 2015 Who is funding the study? Action on Addiction, a UK based charity. Who is the main contact? Garry Stillwell [email protected]

Critère d'inclusion

• Opiate dependency

Liens

• ictrp
• isrctn