Modulation of Opioid Effects by Garlic Supplements
21 Years
45 Years
Both
Healthy, no Evidence of Disease
Trial Information
Modulation of Opioid Effects by Garlic Supplements
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Healthy volunteer
- Body mass index 20-32
PATIENT CHARACTERISTICS:
- Not pregnant
- No history of cardiopulmonary, liver, renal, endocrine, neurologic, or psychiatric
disease
- No anemia
- No known adverse reactions to opioids, benzodiazepines, cardiac glycosides, or garlic
supplements
- No known allergy or hypersensitivity to sulfur-containing food or drugs
- No significant gastrointestinal intolerance to lactose in dairy products
- No recent history of alcohol or substance abuse
- No history of or concurrent heavy daily consumption of allium vegetables (i.e.,
garlic, shallots, leeks, and chives)
- No handicaps due to visual and hearing impairments
- No resting heart rate < 50 beats per minutes
- No abnormal cardiac rhythm by EKG
- No unusually sensitive response or resistance to pain stimulation (cutaneous
electrical stimulation and cold pressor test)
- Must be right handed
- No color blindness
- No history of learning disabilities or dyslexia
- Must be literate and proficient in English
- Must be a nonsmoker
PRIOR CONCURRENT THERAPY:
- No concurrent medication except oral contraceptives
- No concurrent grapefruit or grapefruit juice
- No other concurrent over-the-counter herbal products or herbal tea
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Outcome Measure:
Oxycodone hydrochloride pharmacodynamic measures
Principal Investigator
Danny Shen, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
2040.00
NCT ID:
NCT00499460
Start Date:
November 2006
Completion Date:
September 2008
Related Keywords:
- Healthy, no Evidence of Disease
- healthy, no evidence of disease
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
