Opiate AddictionPhase 3HPDMTNCT01021566
Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis
A Phase 3 study testing Combined hemoperfusion-hemodialysis and Methadone in people with Opiate Addiction, run by First People's Hospital of Foshan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Combined hemoperfusion-hemodialysis and Methadone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
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.
Read the 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.
- Conditions
- Opiate Addiction
- Being tested
- Combined hemoperfusion-hemodialysis, Methadone
- Keywords
- Opiate addiction, Withdrawal symptoms, hemoperfusion, hemodialysis, methadone
- Medical subject headings
- Opioid-Related Disorders, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined hemoperfusion-hemodialysisDevice
Combined hemoperfusion-hemodialysis for opiate detoxification for 3 days
MethadoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined hemoperfusion-hemodialysis | Experimental | On admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days. Receives: Device: Combined hemoperfusion-hemodialysis |
| Methadone, conventional treatment for opiate detoxification | Active comparator | On admission thirty patients receive the 10-day methadone treatment regimen. Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Opiate Withdrawal Scale(SOWS-Gossop)
Measured: 15 days
Secondary outcomes (1)
Blood levels of morphine and β-endorphin, and the urine level of morphine.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Foshan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021566
- Sponsor's protocol ID
- 075783161516
- Acronym
- HPDMT
- Status last verified
- Nov 2009
- First submitted
- 27 Nov 2009
- Last updated
- 30 Nov 2009
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis: A Comparison Study With Conventional Methadone Treatment (HPDMT)
- ClinicalTrials.gov ID
- NCT01021566
- Acronym / sponsor ID
- HPDMT / 075783161516
- Conditions
- Opiate Addiction
- Keywords
- Opiate addiction, Withdrawal symptoms, hemoperfusion, hemodialysis, methadone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First People's Hospital of FoshanUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined hemoperfusion-hemodialysis | Experimental | Device: Combined hemoperfusion-hemodialysisOn admission thirty patients will receive the combined hemoperfusion-hemodialysis treatment regimen three hours everyday for three days. |
| Methadone, conventional treatment for opiate detoxification | Active comparator | Drug: MethadoneOn admission thirty patients receive the 10-day methadone treatment regimen. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined hemoperfusion-hemodialysisCombined hemoperfusion-hemodialysis for opiate detoxification for 3 days | Device | Combined hemoperfusion-hemodialysis |
| MethadoneOn 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 | Methadone, conventional treatment for opiate detoxification |
Primary outcome
The Short Opiate Withdrawal Scale(SOWS-Gossop)
Time frame: 15 days
1 secondary outcome
Blood levels of morphine and β-endorphin, and the urine level of morphine.
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined hemoperfusion-hemodialysis and Methadone in people with Opiate Addiction, run by First People's Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Short Opiate Withdrawal Scale(SOWS-Gossop) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2009.