Buprenorphine Disposition and Cyclosporine

The Washington University

Status: Completed

Conditions: Healthy

Treatments: Drug: buprenorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01648270

201202087

Details and patient eligibility

About

The determine the effect of cyclosporine on buprenorphine disposition

Full 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

Enrollment: 25 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

25 participants in 1 patient group

Study Arm

Experimental group

Description:

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

Treatment:

Drug: buprenorphine