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Disposition Effects of Cyclosporin on Buprenorphine (BUPCsa)

This study is currently recruiting participants.
Verified February 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01648270
First received: April 10, 2012
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Drug: buprenorphine
Drug: Cyclosporine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Influence of Cyclosporine on Buprenorphine Disposition and Effect

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Buprenorphine effects on Healthy volunteers [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    These outcomes will be measured by blood and urine collection, and pupil measurements taken during the study days and follow-ups.


Secondary Outcome Measures:
  • Buprenorphine clearance from the body [ Time Frame: Up to 96 hours ] [ Designated as safety issue: No ]
    These outcomes will be measured by blood and urine collection, taken during the study days and follow-ups.

  • Buprenorphine metabolism [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    These outcomes will be measured by blood and urine collection, taken during the study days and follow-ups.

  • Buprenorphine bio-availability [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    These outcomes will be measured by blood and urine collection taken during the study days and follow-ups.

  • Buprenorphine pupil diameter changes [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
    These outcomes will be measured by pupil measurements taken during the study days and follow-ups.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Arm

Subjects will be studied on four occasions. Sessions and drugs are:

  1. Intravenous buprenorphine
  2. Sublingual buprenorphine
  3. Cyclosporine, then intravenous buprenorphine
  4. Sublingual buprenorphine: continue oral cyclosporine for 5 days
 Drug: buprenorphine

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

Other Name: Suboxone, Subutex
Drug: Cyclosporine
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
Other Name: Gengraf, Neoral, Sandimmune, Sangcya

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648270

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63012
Contact: Lesley Hermann-Donahue, RN     314-286-0587     hermannl@anest.wustl.edu    
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Evan Kharasch, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01648270     History of Changes
Other Study ID Numbers: 201202087
Study First Received: April 10, 2012
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
buprenorphine concentration-effect (miosis) relationship

Additional relevant MeSH terms:
Buprenorphine
Cyclosporins
Cyclosporine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013