Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis
HPDMT
Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 27, 2009
CompletedFirst Posted
Study publicly available on registry
November 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 30, 2009
November 1, 2009
1.1 years
November 27, 2009
November 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Short Opiate Withdrawal Scale(SOWS-Gossop)
15 days
Secondary Outcomes (1)
Blood levels of morphine and β-endorphin, and the urine level of morphine.
15 days
Study Arms (2)
Combined hemoperfusion-hemodialysis
EXPERIMENTALOn admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
Methadone, conventional treatment for opiate detoxification
ACTIVE COMPARATOROn admission thirty patients receive the 10-day methadone treatment regimen.
Interventions
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 27, 2009
First Posted
November 30, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
November 30, 2009
Record last verified: 2009-11