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:

  1. Intravenous buprenorphine
  2. Sublingual buprenorphine
  3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
  4. 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 ]

These outcomes will be measured by blood and urine collection, and pupil measurements taken during the study days and follow-ups.


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 ]

These outcomes will be measured by blood and urine collection, and pupil measurements taken during the study days and follow-ups.


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