Effects of Garlic Supplements on Opioids in Healthy Volunteers

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting its effectiveness as an opioid analgesic for the relief of moderate or severe pain.

PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Digoxin; Midazolam; Oxycodone

Criteria

INCLUSION CRITERIA:

• Healthy volunteer

• Body mass index 20-32

EXCLUSION CRITERIA:

• 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 (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

• No concurrent medication except oral contraceptives

• No concurrent grapefruit or grapefruit juice

• No other concurrent over-the-counter herbal products or herbal tea