Buprenorphine Disposition and Cyclosporine

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: buprenorphine

• Registration Number: NCT01648270
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The determine the effect of cyclosporine on buprenorphine disposition

Detailed Description

Subjects studied on four occasions:

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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-06-20
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Results First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Study Arm	buprenorphine	Subjects will be studied on four occasions. Sessions and drugs are: 1. Intravenous buprenorphine 2. Sublingual buprenorphine 3. Cyclosporine plus intravenous buprenorphine 4. Cyclosporine plus sublingual buprenorphine

Primary Outcome Measures

Name	Time	Method
Buprenorphine Plasma Cmax	96 hours

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States