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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


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 concentration

Methadone 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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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