Overview

This trial is active, not recruiting.

Condition healthy
Treatments buprenorphine, cyclosporine
Sponsor Washington University School of Medicine
Start date April 2012
End date December 2016
Trial size 29 participants
Trial identifier NCT01648270, 201202087

Summary

The purpose of this study is to see how healthy volunteers bodies handle buprenorphine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Subjects will be studied on four occasions. Sessions and drugs are: Intravenous buprenorphine Sublingual buprenorphine Cyclosporine, then intravenous buprenorphine Sublingual buprenorphine: continue oral cyclosporine for 5 days
buprenorphine Suboxone, Subutex
Session 1 Intravenous buprenorphine: 0.2 mg infused over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3intravenous buprenorphine 0.2 mg infused over 1 hr beginning 1 hr after starting cyclosporine. Session 4 Sublingual buprenorphine: 2 mg
cyclosporine Gengraf, Neoral, Sandimmune, Sangcya
Session 3 Cyclosporine (2.5mg/kg/hr infused over 2 hr) Subjects then take oral cyclosporine 4.5 mg/kg twice daily, until session 4, continue oral cyclosporine 4.5 mg/kg twice daily for 5 days

Primary Outcomes

Measure
Buprenorphine effects on Healthy volunteers
time frame: up to 96 hours

Secondary Outcomes

Measure
Buprenorphine clearance from the body
time frame: Up to 96 hours
Buprenorphine metabolism
time frame: up to 96 hours
Buprenorphine bio-availability
time frame: up to 96 hours
Buprenorphine pupil diameter changes
time frame: up to 96 hours

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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)

Additional Information

Official title Influence of Cyclosporine on Buprenorphine Disposition and Effect
Principal investigator Evan Kharasch, MD, PhD
Description Subjects will be studied on four occasions in the Clinical Research Unit at Washington University School of Medicine. Sessions and drugs are: 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.