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Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)

Primary Purpose

Opiate Addiction

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Combined hemoperfusion-hemodialysis
Methadone
Sponsored by
First People's Hospital of Foshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring Opiate addiction, Withdrawal symptoms, hemoperfusion, hemodialysis, methadone

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the First People's Hospital of Foshan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined hemoperfusion-hemodialysis

Methadone, conventional treatment for opiate detoxification

Arm Description

On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.

On admission thirty patients receive the 10-day methadone treatment regimen.

Outcomes

Primary Outcome Measures

The Short Opiate Withdrawal Scale(SOWS-Gossop)

Secondary Outcome Measures

Blood levels of morphine and β-endorphin, and the urine level of morphine.

Full Information

First Posted
November 27, 2009
Last Updated
November 27, 2009
Sponsor
First People's Hospital of Foshan
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1. Study Identification

Unique Protocol Identification Number
NCT01021566
Brief Title
Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis
Acronym
HPDMT
Official Title
Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
First People's Hospital of Foshan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
Opiate addiction, Withdrawal symptoms, hemoperfusion, hemodialysis, methadone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined hemoperfusion-hemodialysis
Arm Type
Experimental
Arm Description
On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
Arm Title
Methadone, conventional treatment for opiate detoxification
Arm Type
Active Comparator
Arm Description
On admission thirty patients receive the 10-day methadone treatment regimen.
Intervention Type
Device
Intervention Name(s)
Combined hemoperfusion-hemodialysis
Intervention Description
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Short Opiate Withdrawal Scale(SOWS-Gossop)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Blood levels of morphine and β-endorphin, and the urine level of morphine.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
the First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China

12. IPD Sharing Statement

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Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis

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