Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)
Recruitment status was: Active, not recruiting
|Opiate Addiction||Device: Combined hemoperfusion-hemodialysis Drug: Methadone||Phase 3|
First People's Hospital of Foshan has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)|
- 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 ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021566
|the First People's Hospital of Foshan|
|Foshan, Guangdong, China, 528000|