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CYP2B6 Polymorphisms in Methadone Disposition

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.
 
ClinicalTrials.gov Identifier: NCT01648283
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: IV racemic methadone HCl Drug: Oral racemic methadone HCl Not Applicable

Detailed Description:
This investigation determined the influence of CYP2B6 genetic variation, specifically CYP2B6*6 polymorphism, on clinical methadone plasma concentrations, clearance, and metabolism. The hypothesis was that CYP2B6*6 heterozygotes or homozygotes would have reduced metabolism and clearance. A secondary objective was to evaluate other less common genotypic variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6*1/*1, CYP2B6*1/*6 , and CYP2B6*6/*6, and also CYP2B6*4 and CYP2B6*5 carriers, received single doses of IV and oral methadone. Plasma and urine methadone and metabolite concentrations were determined by tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as plasma metabolite/patent area under the concentration-time curve ratio and metabolite formation clearance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
Actual Study Start Date : November 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methadone arm
  1. Intravenous racemic methadone HCl, 6.0 mg bolus
  2. Oral deuterated racemic methadone HCl, 11 mg capsule (IND#58,511)
Drug: IV racemic methadone HCl
IV racemic Methadone HC1 6 mg

Drug: Oral racemic methadone HCl
oral d5-methadone HCl 11 mg




Primary Outcome Measures :
  1. Methadone Metabolism [ Time Frame: up to 96 hours ]
    Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio



Information from the National Library of Medicine

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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)

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

Study Data/Documents: Publication  This link exits the ClinicalTrials.gov site
Study results published Anesthesiology. 2015 Nov;123(5):1142-53. doi: 10.1097/ALN.0000000000000867

Publications of Results:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01648283    
Other Study ID Numbers: 201203105
First Posted: July 24, 2012    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: June 2018
Keywords provided by Washington University School of Medicine:
methadone polymorphisms
Additional relevant MeSH terms:
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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