We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

CYP2B6 Polymorphisms in Methadone

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648283
First Posted: July 24, 2012
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance

Resource links provided by NLM:


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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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: March 2018
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648283


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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01648283     History of Changes
Other Study ID Numbers: 201203105
First Submitted: June 6, 2012
First Posted: July 24, 2012
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Washington University School of Medicine:
methadone polymorphisms

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