Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- prevalence of non-users of street opioid after one year of treatment will be compared between arms.
研究概览
简要总结
The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.
This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.
详细描述
We aimed to test the non inferiority of the proportion of non users of street-opioids after one year of treatment in patients inducted in primary care (PC) vs.those inducted in a specialised center for substance dependence (CSAPA).
In this multisite, open-label, randomised controlled non-inferiority trial, opioid dependent individuals were randomized to start methadone either in PC or in a CSAPA. After stabilization of methadone dosage (~2 weeks), patients could change arm. Follow-up assessments through medical questionnaires and phone interviews was scheduled at month 0 (M0, enrolment) M3, M6, M12. The opiate treatment index (OTI) was used for computing the proportion of patients reporting no use of street opioids in the last month at M12 (primary outcome) in those inducted in PC or in a CSAPA and the non inferiority margins.
Primary analysis was by intention to treat (ITT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years patients needing methadone for their opioid dependence who are either naives of methadone treatment (prescribed) since at least 1 month
- •need to switch from buprenorphine to methadone treatment
- •negative test for pregnancy
排除标准
- •co-dependent on alcohol and benzodiazepines,
- •pregnant women,
- •individual in irregular situation or who cannot be joined by phone.
研究组 & 干预措施
A
Methadone inducted by a primary care physician
干预措施: Methadone (Drug)
B
Methadone inducted (in CSAPA)
干预措施: Methadone (Drug)
结局指标
主要结局
prevalence of non-users of street opioid after one year of treatment will be compared between arms.
时间窗: one year
次要结局
- Prevalence of non users of street opioids after three months of treatment(three months)
- Retention in treatment(one year)
- Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts(one year)
- cost-effectiveness(one year)
- surveillance of severe adverse events and overdose cases in each arm(Day -7 to Month 12)