NCT00367874已完成4 期
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Sorlandet Hospital HF2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2003年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Withdrawal symptoms
研究概览
简要总结
Managed detoxification is a first and necessary step prior to treatment and rehabilitation. Detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for long-term treatment.
In our clinical practice we have felt the need for a standardised and safe detoxification treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.
Objectives
- To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined with Carbamazepine (CBZ).
- To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
- To assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Polydrug dependency (at least opiate and benzodiazepine dependency)
排除标准
- •No severe psychiatric illness
- •No history of epilepsy seizures
- •No pregnancy or breastfeeding
- •Fertile women must use contraceptives
结局指标
主要结局
Withdrawal symptoms
Retention in treatment
次要结局
- Serum concentration of Valproate and Buprenorphine separately and in combination
- Urine testing
研究者
研究点 (2)
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