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Effect of CYP2B6 genotype and efavirenz on the disposition and pharmacodynamic of methadone and tizanidine in healthy volunteers
Z
Zeruesenay Desta
Primary Investigator
Recruiting
18 years - 65 years
All
Phase
N/A
72 participants needed
1 Location
Brief description of study
What is this study about?
The purpose of this study is to see how efavirenz, a widely used medication to treat HIV infection, interacts with methadone (a medication used to treat addiction problems and pain) and tizanidine (a medication used to relax muscle) when taken at the same time.
The information learned in this study will help to inform doctors as to how to appropriately adjust doses of efavirenz, methadone and tizanidine to improve health outcomes and long-term treatment success for HIV patients.
Who can participate?
Healthy adults who are able to refrain from taking certain medications during the study period.
Detailed description of study
What happens during study participation?
1) Attend a short Screening visit to verify health and eligibility.
2) If you are eligible and choose to participate, you will be asked to do the following:
- Take three FDA-approved medications
- Have blood and urine collected
- Stay overnight for two inpatient visits (meals will be provided)
- Attend 4 brief outpatient visits
- Keep a medication diary for 16 days of at-home study medication
- All study visits will be performed at the Indiana Clinical Research Center (ICRC) at Indiana University Hospital in Indianapolis, IN
Incentive/compensation
- Participants may earn $1000 for completing all of the study requirements
Additional information
Study title: Effect of CYP2B6 genotype and efavirenz on the disposition and pharmacodynamic of methadone and tizanidine in healthy volunteers
This study is being conducted by Dr. Zeruesenay Desta, Professor of Medicine, Division of Clinical Pharmacology/Department of medicine Indiana University School of Medicine.
To learn more about PI Zeruesenay Desta, PhD and his research interests, please visit this link:
https://medicine.iu.edu/faculty/4934/desta-zeruesenay
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy
-
Age: 18 years - 65 years
-
Gender: All
Inclusion Criteria:
- Overall general good health
- Healthy body weight (BMI less than or equal to 32)
- Able to refrain from taking medications or supplements that may interfere with the 3 FDA-approved study medications
Exclusion Criteria:
- Have any significant health condition
- Currently pregnant
- Unwilling to refrain from alcoholic drinks during study period
- Unwilling to refrain from drugs of abuse (including tobacco and/or marijuana) during the study
- Unable to refrain from taking medications or supplements that may interfere with the 3 FDA-approved study medications
Updated on
01 Aug 2024.
Study ID: 17726
Pre-Screener
