CYP2B6 Polymorphisms in Methadone Disposition
Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
1 other identifier
interventional
78
1 country
1
Brief Summary
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy-volunteers
Started Nov 2012
Longer than P75 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
June 20, 2018
CompletedJune 20, 2018
June 1, 2018
2.3 years
June 6, 2012
February 7, 2018
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Methadone Metabolism
Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio
up to 96 hours
Study Arms (1)
Methadone arm
EXPERIMENTAL1. Intravenous racemic methadone HCl, 6.0 mg bolus 2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511)
Interventions
Eligibility Criteria
You may qualify if:
- Each subject must meet all of the following criteria:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University Schoool of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Kharasch ED, Regina KJ, Blood J, Friedel C. Methadone Pharmacogenetics: CYP2B6 Polymorphisms Determine Plasma Concentrations, Clearance, and Metabolism. Anesthesiology. 2015 Nov;123(5):1142-53. doi: 10.1097/ALN.0000000000000867.
PMID: 26389554RESULT
Results Point of Contact
- Title
- Evan D. Kharasch, MD, PhD
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Kharasch, MD, PhD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
July 24, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2015
Study Completion
June 1, 2015
Last Updated
June 20, 2018
Results First Posted
June 20, 2018
Record last verified: 2018-06