Therapeutic Drug Monitoring and Pharmacogenomics Study of Methadone Therapy (M0108)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heroin-addicted Patients Who Undertook Methadone Maintenance Treatment |
Other: no intervention applied |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2008 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| treatment group |
Other: no intervention applied
no intervention applied
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
heroin-addicted patients
Inclusion Criteria:
- 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
Exclusion Criteria:
Patients with comorbid severe mental disorders including:
- Organic mental disorders, or
- Schizophrenia
- Severe cognitive impairment
Contacts and Locations| Contact: Chun-Yu Chen, MS | 886-37-246166 ext 36747 | cyc@nhri.org.tw |
| Taiwan | |
| Departments of Psychiatry, Wei-Gong Memorial Hospital | Recruiting |
| Miaoli, Taiwan | |
| Principal Investigator: Ming-Lun Liu, MD | |
| Departments of Psychiatry, China Medical University and Hospital | Recruiting |
| Taichung, Taiwan | |
| Principal Investigator: Chieh-Liang Huang, MD | |
| Departments of Psychiatry, Taipei City Hospital Song-De Campus | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: Lien-Wen Su, MD | |
| Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: Yih-Hong Yang, MD | |
| Sub-Investigator: Yung-Chun Fang, MD | |
| Departments of Psychiatry, En-Chu-Kong Hospital | Recruiting |
| Taipei County, Taiwan | |
| Principal Investigator: Li-Nen Lin, MD | |
| Sub-Investigator: Yen-Feng Lin, MD | |
| Departments of Psychiatry, Far-Eastern Memorial Hospital | Recruiting |
| Taipei County, Taiwan | |
| Principal Investigator: Chi-Shin Wu, MD | |
| Sub-Investigator: Kai-Chi Fang, MD | |
| Departments of Psychiatry, Tao-yuan Psychiatric Center | Recruiting |
| Tao-Yuan, Taiwan | |
| Contact: Happy Kuy-Lok Tan, MD, MPH | |
| Principal Investigator: Happy Kuy-Lok Tan, MD, MPH | |
| Sub-Investigator: Sun-Yuan Chou, MD | |
| Sub-Investigator: Kuen-Hong Wu, MD | |
| Principal Investigator: | Sheng-Chang Wang, MD | National Health Research Institutes, Taiwan |
More Information
Additional Information:
No publications provided by National Health Research Institutes, Taiwan
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Keh-Ming Lin, Director, Division of Mental Health and Addiction Medicine, National Health Research Instiutes, Taiwan |
| ClinicalTrials.gov Identifier: | NCT01059747 History of Changes |
| Other Study ID Numbers: | 98A1-PHPP41 |
| Study First Received: | January 29, 2010 |
| Last Updated: | January 29, 2010 |
| Health Authority: | Taiwan: National Health Research Institutes |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013