Clinical Trial: Disposition Effects of Cyclosporin on Buprenorphine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Influence of Cyclosporine on Buprenorphine Disposition and Effect
Brief Summary: The purpose of this study is to see how healthy volunteers bodies handle buprenorphine.
Detailed Summary:
Subjects will be studied on four occasions in the Clinical Research Unit at Washington University School of Medicine. Sessions and drugs are:
- Intravenous buprenorphine
- Sublingual buprenorphine
- Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
- Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days
Sponsor: Washington University School of Medicine
Current Primary Outcome: Buprenorphine effects on Healthy volunteers [ Time Frame: up to 96 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Buprenorphine clearance from the body [ Time Frame: Up to 96 hours ]These outcomes will be measured by blood and urine collection, taken during the study days and follow-ups.
- Buprenorphine metabolism [ Time Frame: up to 96 hours ]These outcomes will be measured by blood and urine collection, taken during the study days and follow-ups.
- Buprenorphine bio-availability [ Time Frame: up to 96 hours ]These outcomes will be measured by blood and urine collection taken during the study days and follow-ups.
- Buprenorphine pupil diameter changes [ Time Frame: up to 96 hours ]These outcomes will be measured by pupil measurements taken during the study days and follow-ups.
Original Secondary Outcome: Buprenorphine measurements [ Time Frame: up to 96 hours ]
Information By: Washington University School of Medicine
Dates:
Date Received: April 10, 2012
Date Started: April 2012
Date Completion:
Last Updated: May 8, 2017
Last Verified: May 2017