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Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)

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ClinicalTrials.gov Identifier: NCT01021566
Recruitment Status : Unknown
Verified November 2009 by First People's Hospital of Foshan.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2009
Last Update Posted : November 30, 2009
Sponsor:
Information provided by:
First People's Hospital of Foshan

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

Expanded Access : 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021566


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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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    Key Record Dates
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