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Completed

NCT Number: NCT01648270

Buprenorphine Disposition and Cyclosporine

The determine the effect of cyclosporine on buprenorphine disposition

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63012, United States

About this study

Subjects studied on four occasions:

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 yr old
  • Good general health with no remarkable medical conditions
  • BMI < 33
  • Provide informed consent

Exclusion criteria

  • Known history of liver or kidney disease
  • Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A
  • 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 (a routine exclusion from studies of drugs with addiction potential)

Treatment and study plan

buprenorphine

Drug

Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.

Primary outcomes

  1. Buprenorphine Plasma Cmax

    Time frame: 96 hours

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Influence of Cyclosporine on Buprenorphine Disposition

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2012
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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