Recruiting
Phase 1

Methadone

Sponsor:

University of Washington

Code:

NCT00504413

Conditions

Substance-Related Disorders

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

midazolam(drug), digoxin (drug)

Bupropion (drug)

Methadone (drug)

Study Details

Brief summary:

The purpose of this study is to determine to what extent CYP2B6, CYP3A4, and MDR1 polymorphisms affect the metabolism of methadone.

Conditions

Substance-Related Disorders

Study ID

NCT00504413

Start date

Jul, 2007

Status verified date

Oct, 2010

Completion date

Jan, 2011

Anticipated

Primary completion date

Jan, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy
  • Within 25% of ideal body weight

Exclusion Criteria:

  • Pregnant
  • A prisoner
  • Enemy, non-combatant
  • Smoker
  • Have a history of liver disease
  • Have a history of heart disease
  • Have a history of drug abuse
  • Currently on prescription medication

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

midazolam(drug), digoxin (drug)

Midazolam (2mg po) and digoxin (0.5mg po) will be administered one time, an hour apart. Blood concentration will be collected at various points in an 8 hour period.

Bupropion (drug)

Bupropion (150mg po) will be administered one time on a separate visit. Blood concentrations will be collected at various points in a 72 hour period.

Methadone (drug)

Methadone (10mg po) will be administered at a separate visit 2 weeks after the bupropion visit. The dose is given once. Blood concentrations will be measured at various points in a 72 hour period. Pupil constriction will be measured and urine will be collected during this period as well.

Primary outcome measure

  • Explore if there is a correlation between the areas of the concentration curves of probe substrates for CYP3A4 and/or CYP2B6 and Pgp and the area of the concentration curve of methadone. [ Time Frame: two years ]

Central Contacts and Locations

Central contacts

Jean C Dinh, PharmD

206.616.2775jeandinh@u.washington.edu

Rheem A Totah, PhD

206.543.9481rtotah@u.washington.edu

Locations

University of Washington General Clinical Research Center

Recruiting

Seattle, Washington, United States, 98105

Principal Investigator:

Rheem A Totah, PhD

More Information

Sponsor

University of Washington

Last update posted

Oct 13, 2010

Last verified

Oct, 2010

Keywords

  • Metabolic Networks and Pathways
  • Methadone
  • Polymorphism, genetic
  • Cytochrome P-450 Enzyme System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2010-10-13.