Heroin-addicted Patients Who Undertook Methadone Maintenance TreatmentM0108NCT01059747
Therapeutic Drug Monitoring and Pharmacogenomics Study of Methadone Therapy
An observational study of Heroin-addicted Patients Who Undertook Methadone Maintenance Treatment, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.
Trial summary
Addiction has been regarded as one of the most serious health and social problems in Taiwan, and heroin is currently considered to be the major substance of abuse. The most widely used treatment to date is methadone replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heroin-addicted Patients Who Undertook Methadone Maintenance Treatment
- How many people
- 500 participants
- Where
- 7 sitesTaiwan
- Study dates
- Dec 2008to not given
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: heroin-addicted patients
Who may be able to join
- Chinese ethnicity
- Men or women above age of 18
- Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
- Diagnosis of Heroin dependence by DSM-IV definition
- Enter methadone maintenance therapy for at least 3 months
- No change of methadone dosage for the last week
- Regularly took methadone for the last week
- Individuals who have completed a written consent form
Who cannot join
- Patients with comorbid severe mental disorders including:
- Organic mental disorders, or
- Schizophrenia
- Severe cognitive impairment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Recruiting
Departments of Psychiatry, Wei-Gong Memorial Hospital
Miaoli
Ming-Lun Liu, MD
- Recruiting
Departments of Psychiatry, China Medical University and Hospital
Taichung
Chieh-Liang Huang, MD
- Recruiting
Departments of Psychiatry, Taipei City Hospital Song-De Campus
Taipei
Lien-Wen Su, MD
- Recruiting
Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
Taipei
Yih-Hong Yang, MD
Yung-Chun Fang, MD
- Recruiting
Departments of Psychiatry, En-Chu-Kong Hospital
Taipei County
Li-Nen Lin, MD
Yen-Feng Lin, MD
- Recruiting
Departments of Psychiatry, Far-Eastern Memorial Hospital
Taipei County
Chi-Shin Wu, MD
Kai-Chi Fang, MD
- Recruiting
Departments of Psychiatry, Tao-yuan Psychiatric Center
Taoyuan
Happy Kuy-Lok Tan, MD, MPH
Happy Kuy-Lok Tan, MD, MPH
About this study
Addiction has been regarded as one of the most serious health and social problems in Taiwan, and heroin is currently considered to be the major substance of abuse. The most widely used treatment to date is methadone replacement therapy. It is reported that to achieve a better clinical response and to avoid possible side effects, the blood level of methadone should remain in a certain level. However, the blood level of methadone is mediated by various factors besides dosage. Genetic variability in genes that encodes enzymes affecting methadone metabolism, target receptors of methadone, and drug-drug interaction by other medication patients take will all affect blood level. Therefore, therapeutic drug monitoring (TDM) and pharmacogenomic study is crucial for evaluating and predicting the clinical response, cause of side effects or toxicity, as well as studies on drug-drug interactions.
This is a cross-sectional study in order to evaluate the relationship between methadone plasma level and clinical response in patients under methadone maintenance therapy and to identify optimal therapeutic thresholds. HPLC will be used to analyze methadone and its metabolites. Our hypothesis is that methadone plasma levels in patients who are responsive to methadone maintenance therapy are higher than level in non-responsive patients, and higher plasma level leads to less severe withdrawal symptoms. We will also test if an optimal minimal dosage exists among these patients. In the meanwhile, we will aim to test if methadone level and clinical response is correlated with different genetic polymorphism. Candidate genes that involve in pharmacokinetic and pharmacodynamic process of methadone (e.g. CYP3A4, CYP3A5, CYP2B6, ABCB1, opioid mu receptor and kappa receptor) will be genotyped for these analyses.
The results of this study will provide clinical information of methadone treatment and pharmacogenomic data in Taiwanese for clinicians to achieve a better treatment outcome.
- Being tested
- no intervention applied
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention appliedOther
no intervention applied
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Not described Receives: Other: no intervention applied |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heroin-addicted Patients Who Undertook Methadone Maintenance TreatmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Investigators
- Sheng-Chang Wang, MD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059747
- Sponsor's protocol ID
- 98A1-PHPP41
- Acronym
- M0108
- Status last verified
- Jan 2010
- First submitted
- 29 Jan 2010
- Last updated
- 1 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu SW, Liu YL, Hwang LL, Wang SC, Kuo HW, Wu SL, Dai YW, Liu SC, Ho IK, Chen AC, Hsiao CF, Tsou HH. Chemokine IP-10 is correlated with cardiac responses and status of infection with HIV and HCV in methadone maintenance patients. Int J Cardiol. 2015 Sep 1;194:36-8. doi: 10.1016/j.ijcard.2015.05.055. Epub 2015 May 12. No abstract available.
PubMed 26011262Tsai HJ, Wang SC, Tian JN, Chang TK, Ho IK, Hsiao CF, Chen CH, Tan HK, Lin L, Wu CS, Su LW, Huang CL, Yang YH, Liu ML, Lin KM, Liu YL. PXR polymorphisms interacted with CYP2B6 polymorphisms on methadone metabolites. J Clin Psychopharmacol. 2013 Feb;33(1):137-40. doi: 10.1097/01.jcp.0000426186.34421.de. No abstract available.
PubMed 23288240Wang SC, Tsou HH, Chen CH, Chen YT, Ho IK, Hsiao CF, Chou SY, Lin YF, Fang KC, Huang CL, Su LW, Fang YC, Liu ML, Wu HY, Lin KM, Liu SC, Kuo HW, Chiang IC, Chen AC, Tian JN, Liu YL. Genetic polymorphisms in the opioid receptor mu1 gene are associated with changes in libido and insomnia in methadone maintenance patients. Eur Neuropsychopharmacol. 2012 Oct;22(10):695-703. doi: 10.1016/j.euroneuro.2012.02.002. Epub 2012 Mar 9.
PubMed 22406240
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring and Pharmacogenomics Study of Methadone Therapy
- ClinicalTrials.gov ID
- NCT01059747
- Acronym / sponsor ID
- M0108 / 98A1-PHPP41
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Dec 2008
- First posted
- 1 Feb 2010 (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.
Addiction has been regarded as one of the most serious health and social problems in Taiwan, and heroin is currently considered to be the major substance of abuse. The most widely used treatment to date is methadone replacement therapy. It is reported that to achieve a better clinical response and to avoid possible side effects, the blood level of methadone should remain in a certain level. However, the blood level of methadone is mediated by various factors besides dosage. Genetic variability in genes that encodes enzymes affecting methadone metabolism, target receptors of methadone, and drug-drug interaction by other medication patients take will all affect blood level. Therefore, therapeutic drug monitoring (TDM) and pharmacogenomic study is crucial for evaluating and predicting the clinical response, cause of side effects or toxicity, as well as studies on drug-drug interactions.
This is a cross-sectional study in order to evaluate the relationship between methadone plasma level and clinical response in patients under methadone maintenance therapy and to identify optimal therapeutic thresholds. HPLC will be used to analyze methadone and its metabolites. Our hypothesis is that methadone plasma levels in patients who are responsive to methadone maintenance therapy are higher than level in non-responsive patients, and higher plasma level leads to less severe withdrawal symptoms. We will also test if an optimal minimal dosage exists among these patients. In the meanwhile, we will aim to test if methadone level and clinical response is correlated with different genetic polymorphism. Candidate genes that involve in pharmacokinetic and pharmacodynamic process of methadone (e.g. CYP3A4, CYP3A5, CYP2B6, ABCB1, opioid mu receptor and kappa receptor) will be genotyped for these analyses.
The results of this study will provide clinical information of methadone treatment and pharmacogenomic data in Taiwanese for clinicians to achieve a better treatment outcome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | Other: no intervention applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- heroin-addicted patients
Key inclusion criteria (8 listed)
- Chinese ethnicity
- Men or women above age of 18
- Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
- Diagnosis of Heroin dependence by DSM-IV definition
- Enter methadone maintenance therapy for at least 3 months
Key exclusion criteria (4 listed)
- Patients with comorbid severe mental disorders including:
- Severe cognitive impairment
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 |
|---|---|---|
| no intervention appliedno intervention applied | Other | treatment group |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2010.
- Derived from this study: PubMed 26011262Liu SW, Liu YL, Hwang LL, Wang SC, Kuo HW, Wu SL, Dai YW, Liu SC, Ho IK, Chen AC, Hsiao CF, Tsou HH. Chemokine IP-10 is correlated with cardiac responses and status of infection with HIV and HCV in methadone maintenance patients. Int J Cardiol. 2015 Sep 1;194:36-8. doi: 10.1016/j.ijcard.2015.05.055. Epub 2015 May 12. No abstract available.
- Derived from this study: PubMed 23288240Tsai HJ, Wang SC, Tian JN, Chang TK, Ho IK, Hsiao CF, Chen CH, Tan HK, Lin L, Wu CS, Su LW, Huang CL, Yang YH, Liu ML, Lin KM, Liu YL. PXR polymorphisms interacted with CYP2B6 polymorphisms on methadone metabolites. J Clin Psychopharmacol. 2013 Feb;33(1):137-40. doi: 10.1097/01.jcp.0000426186.34421.de. No abstract available.
- Derived from this study: PubMed 22406240Wang SC, Tsou HH, Chen CH, Chen YT, Ho IK, Hsiao CF, Chou SY, Lin YF, Fang KC, Huang CL, Su LW, Fang YC, Liu ML, Wu HY, Lin KM, Liu SC, Kuo HW, Chiang IC, Chen AC, Tian JN, Liu YL. Genetic polymorphisms in the opioid receptor mu1 gene are associated with changes in libido and insomnia in methadone maintenance patients. Eur Neuropsychopharmacol. 2012 Oct;22(10):695-703. doi: 10.1016/j.euroneuro.2012.02.002. Epub 2012 Mar 9.
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.
Sheng-Chang Wang, MD principal investigator
National Health Research Institutes, Taiwan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin-addicted Patients Who Undertook Methadone Maintenance Treatment, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.
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 8 inclusion and 4 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 1 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. 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.
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?
Contact Chun-Yu Chen, MS (886-37-246166 ext. 36747, cyc@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059747, which also lists 3 linked publications.
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 1 Feb 2010.