- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01648270
Buprenorphine Disposition and Cyclosporine
January 8, 2020 updated by: Washington University School of Medicine
Influence of Cyclosporine on Buprenorphine Disposition
The determine the effect of cyclosporine on buprenorphine disposition
Study Overview
Detailed Description
Subjects studied on four occasions:
- Intravenous buprenorphine
- Sublingual buprenorphine
- Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
- Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63012
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Arm
Subjects will be studied on four occasions. Sessions and drugs are:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Buprenorphine Plasma Cmax
Time Frame: 96 hours
|
96 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evan Kharasch, MD, PhD, Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 10, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 24, 2012
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201202087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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