Buprenorphine Disposition and Clinical Effects (BUP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01576575
First received: April 10, 2012
Last updated: June 16, 2016
Last verified: June 2016
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 10, 2012
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 30, 2016