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