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Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis

Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01021566
Acronym
HPDMT
Enrollment
60
Registered
2009-11-30
Start date
2009-11-30
Completion date
2011-06-30
Last updated
2009-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Addiction

Keywords

Opiate addiction, Withdrawal symptoms, hemoperfusion, hemodialysis, methadone

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.

Interventions

DEVICECombined hemoperfusion-hemodialysis

Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days

DRUGMethadone

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.

Sponsors

First People's Hospital of Foshan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The Short Opiate Withdrawal Scale(SOWS-Gossop)15 days

Secondary

MeasureTime frame
Blood levels of morphine and β-endorphin, and the urine level of morphine.15 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026