Extrait

Background and study aims Illicit heroin (illicit drug) has a very high risk of addiction, the main symptom being compulsive drug use despite significant health and social harms. Currently, the majority of people presenting to specialist NHS community treatment clinics have established harmful illicit opioid addiction (drug addiction) but the addiction to cocaine adds considerable severity and this type of patient has a relatively poorer treatment outcome compared to primary heroin users. In the NHS, the standard treatment to heroin dependence is the prescription of a substitute (full or partial) μ-opioid agonist (a medicine) taken once daily along with general counselling support (TAU). About 60-70% retained in treatment for at least six months. However, not all patients derive a clinical benefit. Some respond initially, then resume heroin use during the treatment; a minority deteriorate progressively during the treatment. A Personalised Behavioural Intervention (PBI) has been developed which adapts and integrates techniques from evidence-based, approved psychological treatment for patients who have not responded to standard treatment. The aim is to enable these patients to refrain from heroin and cocaine use. Who can participate? Patients who attend Lorraine Hewitt House (LHH), an NHS treatment centre in London and who have received at least 6 weeks of treatment within the clinic service but are still using heroin or cocaine What does the study involve? The PBI combined with TAU is compared against TAU alone. Potential participants are selected from those who self-report of heroin use or cocaine use via an interview which is confirmed by an on-site urine test for the presence of these drugs. All participants are provided with written and verbal information about what is required during participation in the study. Those patients refusing to participate receive the standard treatment package at LHH. Participants are randomly allocated to one of two groups using an automated system. Thereafter, participants in the PBI group attend 12 weekly PBI sessions and TAU sessions (case management and general counselling) weekly or fortnightly. Participants in the TAU group only attend case management and general counselling support sessions on a weekly or fortnightly basis. All participants continue to receive treatment as clinically indicated with supervised consumption at community pharmacies. A variety of factors are measured at baseline and at the final follow-up. Further, some of the factors are measured at three points during the 12-week treatment period. In addition, participants are also given the option of participating in two further studies: 1. To provide a DNA sample for research into genetic factor links to treatment response 2. To participate in a longer term study to find out what happens to participants in the study over the next 5 years They are 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). What are the possible benefits and risks of participating? There are no confirmed direct benefits to participants. They are no greater risks than would occur in the standard treatment program. 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? October 2012 to March 2017 Who is funding the study? Action on Addiction (UK) Who is the main contact Prof. John Marsden [email protected]

Critère d'inclusion

• Opiate dependency

Liens

• isrctn
• ictrp