Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Short Opiate Withdrawal Scale(SOWS-Gossop)
研究概览
简要总结
The purpose of this study is to determine whether combined hemoperfusion-hemodialysis treatment is an alternative drug-free, effective, and safe treatment for opiate detoxification.
详细描述
Drug abuse remains a major society problem in our community and is also a major health problem in our modern society. Thus, education to prevent the young generation to avoid drug abuse and detoxification to help those to quite from the drug abuse are two major key steps in the controlling drug abuse program.
Currently, medications for opiate detoxification, such as methadone, are commonly used worldwide. However, methadone is also an addictive medication. When it is stopped suddenly, patients usually produce unpleasant withdrawal symptoms. Meanwhile, methadone is also potentially to be abused too. Thus, it is urgently needed to seek an alternative safer, effective, drug-free method for opiate detoxification. Based on our clinical observation, the timely clearance of toxicities from the body or blood is a safe and effective detoxification method. Thus, we hypothesized that the use of combined hemoperfusion-hemodialysis may be an alternative drug-free, effective, and safe treatment for opiate detoxification. This will be tested in patients who have severe drug abuse and are under custodial conditions by a daily combined hemoperfusion-hemodialysis for 3 days. The efficacy and safety of the hemoperfusion-hemodialysis will be compared to a 10 day standard methadone detoxification treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be fulfilled DSM-IV criteria(American Psychiatric Association) for opiate dependence.
- •A history of current dependence on heroin, which was supported by laboratory results from urine drug screening, using both chromatographic and radioimmunoassay methods.
- •Opioid dependent patients who inject heroin from 0.5g to 1.0g daily by veins for at least 1 year.
- •Haven't received methadone treatment for at least 2 months before entry to this study.
- •Be able to understand and have signed the informed consent.
排除标准
- •Take heroin for the first time.
- •Positive for HIV.
- •The function of cruor or hemorrhage is badly damaged.
- •The number of platelets is lower than 70×10*
- •Co-dependent on substances other than opiates (including alcohol, benzodiazepines, cocaine, or amphetamines).
- •Methadone dose requirement is over 70 mg/day as determined by the 3-day dose assessment period.
- •Have serious physical illness or major psychiatric illness.
- •Pregnant woman.
研究组 & 干预措施
Combined hemoperfusion-hemodialysis
On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
干预措施: Combined hemoperfusion-hemodialysis (Device)
Methadone, conventional treatment for opiate detoxification
On admission thirty patients receive the 10-day methadone treatment regimen.
干预措施: Methadone (Drug)
结局指标
主要结局
The Short Opiate Withdrawal Scale(SOWS-Gossop)
时间窗: 15 days
次要结局
- Blood levels of morphine and β-endorphin, and the urine level of morphine.(15 days)