Clinical trial NCT01021566: Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis
Official title: Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Opiate Addiction
Keywords: Opiate addiction
Withdrawal symptoms
hemoperfusion
hemodialysis
methadone
Lead sponsor: First People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2009-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Short Opiate Withdrawal Scale(SOWS-Gossop)
timeFrame: 15 days
Secondary outcomes:
measure: Blood levels of morphine and β-endorphin, and the urine level of morphine.
timeFrame: 15 days
Other outcomes:
Locations:
city: Foshan
country: China
facility: the First People's Hospital of Foshan
state: Guangdong
Study officials:
References: