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Buprenorphine Disposition and Clinical Effects (BUP)

This study is currently recruiting participants.
Verified June 2016 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576575
First Posted: April 12, 2012
Last Update Posted: June 17, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
The purpose of this study is to determine how people absorb and break down (metabolize) and eliminate buprenorphine and if CYP3A is involved.

Condition Intervention
Healthy Drug: Buprenorphine Drug: Rifampin Other: grapefruit juice Drug: Ketoconazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Influence of CYP3A Modulation on Buprenorphine Disposition and Clinical Effects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the plasma concentration-time curve (AUC) of BPN and metabolites [ Time Frame: At various times upto 96 hours ]

Estimated Enrollment: 25
Study Start Date: June 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Session 2
IV buprenorphine or sublingual burenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual
Experimental: Session 3
Rifampin and IV buprenorphine or sublingual burenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual
Drug: Rifampin
600 mg orally for 7 days
Experimental: Session 4
Rifampin and IV buprenorphine or sublingual burenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual
Drug: Rifampin
600 mg orally for 7 days
Experimental: Session 5
Grapefruit juice and sublingual buprenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual
Other: grapefruit juice
8 oz at bedtime and 3oz in the morning.
Experimental: Session 6
Ketoconazole and IV buprenorphine or sublingual burenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual
Drug: Ketoconazole
400 mg orally for 3-4 days
Experimental: Session 7
Ketoconazole and IV buprenorphine or sublingual burenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual
Drug: Ketoconazole
400 mg orally for 3-4 days
Experimental: Session 1
IV buprenorphine or sublingual burenorphine
Drug: Buprenorphine
.2 mg IV or 2-4 mg sublingual

  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:

Each subject must meet all of the following criteria:

  1. Male or non-pregnant female volunteer, 18-50 yr old
  2. Good general health with no known major medical conditions
  3. BMI between 20-33
  4. Provide informed consent

Exclusion Criteria:

Subjects will not be enrolled if any of the following criteria exist:

  1. Known history of liver or kidney disease
  2. Use of prescription or non-prescription medications, herbals or foods known to be metabolized by or affect CYP3A activity (this includes the use of oral contraceptives).
  3. Females who are pregnant or nursing
  4. Known history of drug or alcohol addiction (prior or present addiction or addiction treatment)
  5. Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is 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): NCT01576575


Contacts
Contact: Kristi Kraus 314-747-0421 krausk@anest.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kalin Guebert    314-747-1663    kguebert@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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01576575     History of Changes
Other Study ID Numbers: 201104146
First Submitted: April 10, 2012
First Posted: April 12, 2012
Last Update Posted: June 17, 2016
Last Verified: June 2016

Keywords provided by Washington University School of Medicine:
to determine how people absorb and break down (metabolize) and eliminate buprenorphine and if CYP3A is involved.

Additional relevant MeSH terms:
Buprenorphine
Ketoconazole
Rifampin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers