Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis

Phase 3

• Conditions: Opiate Addiction
• Interventions: Device: Combined hemoperfusion-hemodialysis; Drug: Methadone

• Registration Number: NCT01021566
• Lead Sponsor: First People's Hospital of Foshan

Brief Summary

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

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.

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Last Update Submitted: 2009-11-27
• Study First Posted: 2009-11-30
• Last Update Posted: 2009-11-30
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined hemoperfusion-hemodialysis	Combined hemoperfusion-hemodialysis	On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
Methadone, conventional treatment for opiate detoxification	Methadone	On admission thirty patients receive the 10-day methadone treatment regimen.

Primary Outcome Measures

Name	Time	Method
The Short Opiate Withdrawal Scale(SOWS-Gossop)	15 days

Secondary Outcome Measures

Name	Time	Method
Blood levels of morphine and β-endorphin, and the urine level of morphine.	15 days

Trial Locations

Locations (1)

the First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China