Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Opiate Addiction	Device: Combined hemoperfusion-hemodialysis; Drug: Methadone	Phase 3

First People's Hospital of Foshan has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
Study Start Date :	November 2009
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	June 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Combined hemoperfusion-hemodialysis; On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.	Device: Combined hemoperfusion-hemodialysis; Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
Active Comparator: Methadone, conventional treatment for opiate detoxification; On admission thirty patients receive the 10-day methadone treatment regimen.	Drug: 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.

Outcome Measures

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Primary Outcome Measures :

1. The Short Opiate Withdrawal Scale(SOWS-Gossop) [ Time Frame: 15 days ]

Secondary Outcome Measures :

1. Blood levels of morphine and β-endorphin, and the urine level of morphine. [ Time Frame: 15 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

China, Guangdong
the First People's Hospital of Foshan
Foshan, Guangdong, China, 528000

Sponsors and Collaborators

First People's Hospital of Foshan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	the First People's Hospital of Foshan
ClinicalTrials.gov Identifier:	NCT01021566 History of Changes
Other Study ID Numbers:	075783161516
First Posted:	November 30, 2009
Last Update Posted:	November 30, 2009
Last Verified:	November 2009

Keywords provided by First People's Hospital of Foshan:

Opiate addiction; Withdrawal symptoms; hemoperfusion; hemodialysis; methadone

Additional relevant MeSH terms:

Behavior, Addictive; Opioid-Related Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Methadone; Opiate Alkaloids	Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antitussive Agents; Respiratory System Agents