Opioid Dependence Clinical Trial
Official title:
Influence of KCNH2 Polymorphisms on the QTc Interval in Kelantanese Malays Patients Receiving Methadone Maintenance Therapy (MMT) in Malaysia
Verified date | July 2018 |
Source | University of Science Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Methadone maintenance therapy (MMT) is one of the modalities to prevent HIV transmission among injected drug users, particularly in opioid-dependent users. However, methadone-associated cardiotoxicity is one of the fatal adverse events that limit the widespread usage in certain groups of opioid-dependent patients. This is a cross-sectional study aimed to investigate the association between 4 KCNH2 SNPs (1539C>T, in exon 6 of KCNH2 gene; 1956T>C, in exon 8 of KCNH2 gene), 2350C>T (in exon 9 of KCNH2 gene), 2690A>C (Exon 11 of KCNH2 gene)) and prolongation of QTc interval in opioid-dependent Kelantanese Malays who are the recipients of Methadone Maintenance Therapy. The investigators hypothesized that subjects with minor alleles of those 4 SNPs will have longer QTc intervals than those with major alleles, adjusting for the effects of other confounding factors such as age and gender of the subjects, plasma methadone trough levels, hypokalemia, hypocalcemia and hypomagnesemia. The investigators also aimed to provide a model that will reliably predict the magnitude QTc based on the SNPs data and other covariates mentioned above. This will greatly assist in identifying methadone recipients who are at risk of developing prolonged QTc or the more fatal torsade de pointes.
Status | Completed |
Enrollment | 111 |
Est. completion date | December 31, 2012 |
Est. primary completion date | December 31, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Opioid-dependent subjects aged 18 years and above - Opioid-dependent subjects who were on Methadone Maintenance Therapy (MMT) for 6 months or longer and had stable plasma methadone concentration - Malay ancestry up to 3 generations - A history of good compliance with Directly-Observed Therapy (DOT) Exclusion Criteria: - Opioid-dependent subjects who were aggressive and had active psychiatric illnesses - Opioid-dependent subjects with chronic medical and surgical illnesses - Opioid-dependent subjects with cardiac structural defects - Inability to communicate in Malay or English |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
University of Science Malaysia |
Malaysia,
Hajj A, Ksouda K, Peoc'h K, Curis E, Messali A, Deveaux LL, Bloch V, Prince N, Mouly S, Scherrmann JM, Lépine JP, Laplanche JL, Drici MD, Vorspan F. KCNH2 polymorphism and methadone dosage interact to enhance QT duration. Drug Alcohol Depend. 2014 Aug 1;1 — View Citation
Koo SH, Ho WF, Lee EJ. Genetic polymorphisms in KCNQ1, HERG, KCNE1 and KCNE2 genes in the Chinese, Malay and Indian populations of Singapore. Br J Clin Pharmacol. 2006 Mar;61(3):301-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QTc Interval | QT interval (measured in milliseconds) obtained from ECG reading that is then divided by the shortest R-R interval to the power of 0.33 (Fredericia's formula). | First screening visit |
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