Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis

Opiate Addiction Clinical Trial

— HPDMT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01021566
• Other study ID #: 075783161516
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 27, 2009
• Last updated: November 27, 2009
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2009
• Source: First People's Hospital of Foshan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Addiction

Intervention

Device:
• Combined hemoperfusion-hemodialysis
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days

Drug:
• 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.

Locations

Country	Name	City	State
China	the First People's Hospital of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Short Opiate Withdrawal Scale(SOWS-Gossop)		15 days	Yes
Secondary	Blood levels of morphine and ß-endorphin, and the urine level of morphine.		15 days	Yes