Therapeutic Drug Monitoring and Pharmacogenomics Study of Methadone Therapy

NCT01059747 | Unknown

• 1 other identifier: 98A1-PHPP41
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

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.

Conditions

Heroin-addicted Patients Who Undertook Methadone Maintenance Treatment

Study Arms (1)

treatment group

Other: no intervention applied

Interventions

no intervention applied OTHER

no intervention applied

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

heroin-addicted patients

You may qualify if:

• 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

You may not qualify if:

• Patients with comorbid severe mental disorders including:
• Organic mental disorders, or
• Schizophrenia
• Severe cognitive impairment

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (7)

Departments of Psychiatry, Wei-Gong Memorial Hospital

Miaoli, Taiwan

RECRUITING

Departments of Psychiatry, China Medical University and Hospital

Taichung, Taiwan

RECRUITING

Departments of Psychiatry, Taipei City Hospital Song-De Campus

Taipei, Taiwan

RECRUITING

Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus

Taipei, Taiwan

RECRUITING

Departments of Psychiatry, En-Chu-Kong Hospital

Taipei County, Taiwan

RECRUITING

Departments of Psychiatry, Far-Eastern Memorial Hospital

Taipei County, Taiwan

RECRUITING

Departments of Psychiatry, Tao-yuan Psychiatric Center

Taoyuan District, Taiwan

RECRUITING

Related Publications (3)

• 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.

  PMID: 26011262 DERIVED

• Tsai 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.

  PMID: 23288240 DERIVED

• Wang 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.

  PMID: 22406240 DERIVED

Study Officials

• Sheng-Chang Wang, MD

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Chen, MS

CONTACT

886-37-246166; cyc@nhri.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 1, 2010
• Study Start: December 1, 2008
• Last Updated: February 1, 2010

Record last verified: 2010-01

Locations

TW (7)