Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis
NCT ID: NCT01021566
Last Updated: 2009-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2009-11-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combined hemoperfusion-hemodialysis
On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
Combined hemoperfusion-hemodialysis
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
Methadone, conventional treatment for opiate detoxification
On admission thirty patients receive the 10-day methadone treatment regimen.
Methadone
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.
Interventions
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Combined hemoperfusion-hemodialysis
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
Methadone
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
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First People's Hospital of Foshan
OTHER
Responsible Party
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the First People's Hospital of Foshan
Locations
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the First People's Hospital of Foshan
Foshan, Guangdong, China
Countries
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Other Identifiers
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075783161516
Identifier Type: -
Identifier Source: org_study_id