Graded Strategy for Pharmacological Treatment of Heroin Dependence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Retention in treatment
研究概览
简要总结
The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.
详细描述
The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.
For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heroin dependence according to DSM IV > 1year
- •Age > 20 years
- •Acceptance of the stated treatment principles.
排除标准
- •Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
- •Other clinically significant psychiatric illness unless stable under treatment
- •Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
- •Other clinically significant medical condition unless stable under treatment
- •Treatment with anti-seizure drugs or disulfiram
- •Pregnancy or intent to become pregnant within the next year
- •Ongoing nursing
- •Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible.
结局指标
主要结局
Retention in treatment
次要结局
- Proportion urine samples free of illicit drugs
- Problem severity as measured by Addiction Severity Index