Buprenorphine Disposition and Cyclosporine

NCT ID: NCT01648270

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-12-31

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

Conditions

Healthy

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Arm

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

Group Type: EXPERIMENTAL

buprenorphine

Intervention Type: 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.

Interventions

buprenorphine

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Kharasch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201202087

Identifier Type: -

Identifier Source: org_study_id