Therapeutic Drug Monitoring and Pharmacogenomics Study of Methadone Therapy (M0108)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059747
Recruitment Status : Unknown
Verified January 2010 by National Health Research Institutes, Taiwan.
Recruitment status was:  Recruiting
First Posted : February 1, 2010
Last Update Posted : February 1, 2010
Information provided by:
National Health Research Institutes, Taiwan

Brief 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. 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 or disease Intervention/treatment
Heroin-addicted Patients Who Undertook Methadone Maintenance Treatment Other: no intervention applied

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Study Start Date : December 2008

Group/Cohort Intervention/treatment
treatment group Other: no intervention applied
no intervention applied

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
heroin-addicted patients

Inclusion Criteria:

  1. Chinese ethnicity
  2. Men or women above age of 18
  3. Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects)
  4. Diagnosis of Heroin dependence by DSM-IV definition
  5. Enter methadone maintenance therapy for at least 3 months
  6. No change of methadone dosage for the last week
  7. Regularly took methadone for the last week
  8. Individuals who have completed a written consent form

Exclusion Criteria:

  1. Patients with comorbid severe mental disorders including:

    1. Organic mental disorders, or
    2. Schizophrenia
  2. Severe cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059747

Contact: Chun-Yu Chen, MS 886-37-246166 ext 36747

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, 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, 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, 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         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Principal Investigator: Sheng-Chang Wang, MD National Health Research Institutes, Taiwan

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Keh-Ming Lin, Director, Division of Mental Health and Addiction Medicine, National Health Research Instiutes, Taiwan Identifier: NCT01059747     History of Changes
Other Study ID Numbers: 98A1-PHPP41
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: January 2010