Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis (HPDMT)
Recruitment status was Active, not recruiting
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 27, 2009 |
| Last Updated Date | November 27, 2009 |
| Start Date ICMJE | November 2009 |
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
The Short Opiate Withdrawal Scale(SOWS-Gossop) [ Time Frame: 15 days ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE |
Blood levels of morphine and β-endorphin, and the urine level of morphine. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis |
| Official Title ICMJE | Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT) |
| 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. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 3 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Opiate Addiction |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 60 |
| Estimated Completion Date | June 2011 |
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | China |
| Administrative Information | |
| NCT Number ICMJE | NCT01021566 |
| Other Study ID Numbers ICMJE | 075783161516 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | the First People's Hospital of Foshan |
| Study Sponsor ICMJE | First People's Hospital of Foshan |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | First People's Hospital of Foshan |
| Verification Date | November 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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