This trial is active, not recruiting.

Condition healthy volunteers
Treatments racemic methadone hc1, oral deuterated racemic methadone hcl,
Sponsor Washington University School of Medicine
Start date May 2012
End date December 2017
Trial size 80 participants
Trial identifier NCT01648283, 201203105


This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Intravenous racemic methadone HCl, 6.0 mg bolus Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg
racemic methadone hc1
IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg
oral deuterated racemic methadone hcl,
11 mg capsule once

Primary Outcomes

The effects of methadone on healthy volunteers
time frame: up to 96 hours

Secondary Outcomes

Methadone and bupropion concentration
time frame: Up to 96 hours
Methadone and bupropion clearance from the body
time frame: up to 96 hours
Oral methadone and bupropion absorption
time frame: up to 96 hours
Influence of CYP2B6*6 hetero or homozyge genotype on the above primary and secondary outcomes
time frame: up to 96 hours

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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)

Additional Information

Official title Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
Principal investigator Evan Kharasch, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.