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CYP2B6 Polymorphisms in Methadone

This study is currently recruiting participants.
Verified February 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01648283
First received: June 6, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Healthy Volunteers
 Drug: racemic methadone HC1
Drug: Oral deuterated racemic methadone HCl,

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The effects of methadone on healthy volunteers [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    This outcome will be measured by blood draws taken during the study days and follow-ups. This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.


Secondary Outcome Measures:
  • Methadone and bupropion concentration [ Time Frame: Up to 96 hours ] [ Designated as safety issue: No ]
    This outcome will be measured by blood and urine collections, as well as dark pupil measurement.

  • Methadone and bupropion clearance from the body [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    This outcome will be measured by blood and urine collections, as well as dark pupil measurement.

  • Oral methadone and bupropion absorption [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    This outcome will be measured by blood and urine collections, as well as dark pupil measurement.

  • Influence of CYP2B6*6 hetero or homozyge genotype on the above primary and secondary outcomes [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    This outcome will be measured by blood and urine collections, as well as dark pupil measurement.


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methadone arm
  1. Intravenous racemic methadone HCl, 6.0 mg bolus
  2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511) CYP2B6 is phenotyped by the clearance oral racemic bupropion 150mg
 Drug: racemic methadone HC1
IV racemic Methadone HC1 6 mg oral d5-methadon HC1 11 mg
Drug: Oral deuterated racemic methadone HCl,
11 mg capsule once

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648283

Contacts
Contact: Lesley Hermann-donahue, RN 314-286- hermannl@anest.wustl.edu
Contact: Jane Blood, RN 314-747-5531 bloodj@anest.wustl.edu

Locations
United States, Missouri
Washington University Schoool of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Evan D Kharasch, MD, PhD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Evan Kharasch, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01648283     History of Changes
Other Study ID Numbers: 201203105
Study First Received: June 6, 2012
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
methadone polymorphisms

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013