Buprenorphine Disposition and CYP3A

• Status: Completed
• Trial end date: 2014-03-29
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate role of CYP3A in buprenorphine disposition and effect

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Buprenorphine; Ketoconazole; Rifampin

Criteria

Inclusion Criteria:

Each subject must meet all of the following criteria:

1. Male or non-pregnant female volunteer, 18-50 yr old

2. Good general health with no known major medical conditions

3. BMI < 33

4. Provide informed consent

Exclusion Criteria:

Subjects will not be enrolled if any of the following criteria exist:

1. Known history of liver or kidney disease

2. Use of prescription or non-prescription medications, herbals or foods known to be metabolized by or affect CYP3A activity (this includes the use of oral contraceptives).

3. Females who are pregnant or nursing

4. Known history of drug or alcohol addiction (prior or present addiction or addiction treatment)

5. 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)