Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)
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|ClinicalTrials.gov Identifier: NCT01021566|
Recruitment Status : Unknown
Verified November 2009 by First People's Hospital of Foshan.
Recruitment status was: Active, not recruiting
First Posted : November 30, 2009
Last Update Posted : November 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Opiate Addiction||Device: Combined hemoperfusion-hemodialysis Drug: Methadone||Phase 3|
Expanded Access : First People's Hospital of Foshan has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||June 2011|
Experimental: Combined hemoperfusion-hemodialysis
On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days.
Device: Combined hemoperfusion-hemodialysis
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
Active Comparator: Methadone, conventional treatment for opiate detoxification
On admission thirty patients receive the 10-day methadone treatment regimen.
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.
- The Short Opiate Withdrawal Scale(SOWS-Gossop) [ Time Frame: 15 days ]
- Blood levels of morphine and β-endorphin, and the urine level of morphine. [ Time Frame: 15 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021566
|the First People's Hospital of Foshan|
|Foshan, Guangdong, China, 528000|