CYP2B6 Polymorphisms in Methadone
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: racemic methadone HC1 (Drug); Oral deuterated racemic methadone HCl, (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Evan Kharasch, MD, PhD, Principal Investigator, Affiliation: Washington University School of Medicine
Summary
This research study will determine if genetic variation in CYP2B6 affects how the body
metabolizes methadone.
Clinical Details
Official title: Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: The effects of methadone on healthy volunteers
Secondary outcome: Methadone and bupropion concentrationMethadone and bupropion clearance from the body Oral methadone and bupropion absorption Influence of CYP2B6*6 hetero or homozyge genotype on the above primary and secondary outcomes
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Each subject must meet all of the following criteria:
- 18-50 yr old
- CYP2B6*1/*1, CYP2B6*1/*6 or CYP2B6*6/*6 genotype
- Good general health with no remarkable medical conditions
- BMI < 33
- Provided informed consent
Exclusion Criteria:
Subjects will not be enrolled if any of the following criteria exist:
- Known history of liver or kidney disease
- Use of prescription or non prescription medications, herbals or foods known to be
metabolized by or affect CYP2B6
- Females who are pregnant or nursing
- Known history of drug or alcohol addiction (prior or present addiction or treatment
for addiction)
- Direct physical access to and routine handling of addicting drugs in the regular
course of duty (this is a routine exclusion from studies of drugs with addiction
potential)
Locations and Contacts
Washington University Schoool of Medicine, St. Louis, Missouri 63110, United States
Additional Information
Starting date: May 2012
Last updated: August 13, 2015
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