Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by First People's Hospital of Foshan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
First People's Hospital of Foshan
ClinicalTrials.gov Identifier:
NCT01021566
First received: November 27, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 27, 2009
November 27, 2009
November 2009
December 2010   (final data collection date for primary outcome measure)
The Short Opiate Withdrawal Scale(SOWS-Gossop) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Blood levels of morphine and β-endorphin, and the urine level of morphine. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis
Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Addiction
  • Device: Combined hemoperfusion-hemodialysis
    Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
  • 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.
  • Experimental: Combined hemoperfusion-hemodialysis
    On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
    Intervention: Device: Combined hemoperfusion-hemodialysis
  • Active Comparator: Methadone, conventional treatment for opiate detoxification
    On admission thirty patients receive the 10-day methadone treatment regimen.
    Intervention: Drug: Methadone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01021566
075783161516
Not Provided
the First People's Hospital of Foshan
First People's Hospital of Foshan
Not Provided
Not Provided
First People's Hospital of Foshan
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP