Conditions: Healthy
Keywords: buprenorphine CYP3A
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 25
Healthy volunteers: yes

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

Arms:
arm 1: 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

Interventions: intervention 1: buprenorphine
Intervention descriptions: intervention 1: 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.

Protocol document: