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Disposition Effects of Cyclosporin on Buprenorphine (BUPCsa)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648270
First Posted: July 24, 2012
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Cyclosporine on Buprenorphine Disposition and Effect

Resource links provided by NLM:


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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    These outcomes will be measured by pupil measurements taken during the study days and follow-ups.


Enrollment: 29
Study Start Date: April 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648270


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63012
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Evan Kharasch, MD, PhD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01648270     History of Changes
Other Study ID Numbers: 201202087
First Submitted: April 10, 2012
First Posted: July 24, 2012
Last Update Posted: May 9, 2017
Last Verified: May 2017

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

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


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