Overview

This trial is active, not recruiting.

Condition opiate addiction
Treatments combined hemoperfusion-hemodialysis, methadone
Phase phase 3
Sponsor First People's Hospital of Foshan
Start date November 2009
End date December 2010
Trial size 60 participants
Trial identifier NCT01021566, 075783161516

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
combined hemoperfusion-hemodialysis
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
(Active Comparator)
On admission thirty patients receive the 10-day methadone treatment regimen.
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.

Primary Outcomes

Measure
The Short Opiate Withdrawal Scale(SOWS-Gossop)
time frame: 15 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by First People's Hospital of Foshan.