Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)

Conditions
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Opiate Addiction

Intervention / Treatment
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* Device: Combined hemoperfusion-hemodialysis
* Drug: Methadone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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*9. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined hemoperfusion-hemodialysis<br>On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days. | Device: Combined hemoperfusion-hemodialysis<br>* Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days<br>|
| Active Comparator: Methadone, conventional treatment for opiate detoxification<br>On admission thirty patients receive the 10-day methadone treatment regimen. | Drug: Methadone<br>* On admission all patients will undergo a 3-day stabilization period. Then they will begin the 10-day methadone treatment regimen. The starting dose of methadone is determined by the mean daily dose requirement during the stabilization period and the dose will be reduced to zero at a linear rate over the 10 days treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short Opiate Withdrawal Scale(SOWS-Gossop) |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of morphine and β-endorphin, and the urine level of morphine. |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opiate addiction, Withdrawal symptoms, hemoperfusion, hemodialysis, methadone