Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Effect of Garlic Supplements on Opioids in Healthy Volunteers

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Natural history/Epidemiology	Closed	21 to 45	NCI	FHCRC-2040.00 FHCRC-2040.00, FHCRC-2040.00p, NCT00499460

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• Healthy volunteer



• Body mass index 20-32

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

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

Expected Enrollment

Outcomes

Oxycodone hydrochloride pharmacodynamic measures

Oxycodone hydrochloride pharmacokinetic parameters

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Danny Shen, PhD, Principal investigator		Ph: 206-667-4583

Registry Information
Official Title		Modulation of Opioid Effects by Garlic Supplements
Trial Start Date		2006-11-01
Trial Completion Date		2008-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT00499460
Date Submitted to PDQ		2007-05-18
Information Last Verified		2008-04-06
NCI Grant/Contract Number		CA118334, CA15704

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