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Disposition Effects of Cyclosporin on Buprenorphine

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: buprenorphine (Drug); Cyclosporine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Evan Kharasch, MD, PhD, Principal Investigator, Affiliation: Washington University School of Medicine


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

Clinical Details

Official title: Influence of Cyclosporine on Buprenorphine Disposition and Effect

Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Buprenorphine effects on Healthy volunteers

Secondary outcome:

Buprenorphine clearance from the body

Buprenorphine metabolism

Buprenorphine bio-availability

Buprenorphine pupil diameter changes

Detailed 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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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)

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63012, United States; Recruiting
Lesley Hermann-Donahue, RN, Phone: 314-286-0587, Email: hermannl@anest.wustl.edu
Additional Information

Starting date: April 2012
Last updated: June 2, 2015

Page last updated: August 23, 2015

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