N/A
N=78
CYP2B6 Polymorphisms in Methadone Disposition
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01648283 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Methadone Metabolism — 0.082; 0.073; 0.054 ratio — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IV racemic methadone HCl (Drug); Oral racemic methadone HCl (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Methadone Metabolism |
0.082; 0.073; 0.054 | <0.05 sig |
Summary
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01648283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.