Modulation of Opioid Effects by Garlic Supplements
- Determine whether a CYP3A- and P-glycoprotein-dependent interaction exists between
garlic supplements and a commonly used oral opioid analgesic (oxycodone hydrochloride)
in healthy volunteers.
OUTLINE: This is a single-blind, randomized, crossover study. Participants are randomized to
1 of 2 arms.
- Arm I: Participants receive oral garlic twice daily on days 1-28 and oral oxycodone
hydrochloride on days 2 and 28. Participants then receive oral placebo twice daily on
days 58-87 and oral oxycodone hydrochloride on days 60 and 85.
- Arm II: Participants receive oral placebo twice daily on days 1-28 and oral oxycodone
hydrochloride on days 2 and 28. Participants then receive oral garlic twice daily on
days 58-87 and oral oxycodone hydrochloride on days 60-85.
In both arms, participants receive oral midazolam hydrochloride and oral digoxin once on
days 29 and 86. Blood samples are collected periodically and examined by liquid
chromatography-mass spectrometry (LC-MS) for CYP3A4 and P-glycoprotein phenotyping.
Blood and urine samples are collected after receiving oxycodone hydrochloride for
pharmacokinetic-pharmacodynamic studies via LC-MS.
Pain response is assessed at baseline and periodically after oxycodone hydrochloride
treatment via electrical stimulation and the cold pressor test. Side effects of oxycodone
hydrochloride treatment are assessed via questionnaires and tests for cognitive function,
manipulative dexterity, motor speed, and visual attention.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Oxycodone hydrochloride pharmacodynamic measures
Danny Shen, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|