Effect of Garlic Supplements on Opioids in Healthy Volunteers | RxWiki

Effect of Garlic Supplements on Opioids in Healthy Volunteers

Overview[ - collapse ][ - ]

Purpose	RATIONALE: Garlic supplements may change the effectiveness of oxycodone used to relieve moderate or severe pain. PURPOSE: This randomized phase I trial is studying how garlic supplements may change the effectiveness of opioids in healthy volunteers.
Condition	Healthy, no Evidence of Disease
Intervention	Dietary Supplement: garlic Drug: digoxin Drug: midazolam hydrochloride Drug: oxycodone hydrochloride Genetic: gene expression analysis Genetic: protein expression analysis Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study
Phase	Phase 4
Sponsor	Fred Hutchinson Cancer Research Center
Responsible Party	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier	NCT00499460
First Received	July 10, 2007
Last Updated	April 30, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	July 10, 2007
Last Updated Date	April 30, 2012
Start Date	November 2006
Estimated Primary Completion Date	September 2008
Current Primary Outcome Measures	Oxycodone hydrochloride pharmacodynamic measures
Current Secondary Outcome Measures	Oxycodone hydrochloride pharmacokinetic parameters

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Garlic Supplements on Opioids in Healthy Volunteers
Official Title	Modulation of Opioid Effects by Garlic Supplements
Brief Summary	RATIONALE: Garlic supplements may change the effectiveness of oxycodone used to relieve moderate or severe pain. PURPOSE: This randomized phase I trial is studying how garlic supplements may change the effectiveness of opioids in healthy volunteers.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Condition	Healthy, no Evidence of Disease
Intervention	Dietary Supplement: garlic Drug: digoxin Drug: midazolam hydrochloride Drug: oxycodone hydrochloride Genetic: gene expression analysis Genetic: protein expression analysis Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study
Study Arm (s)	Active Comparator: Garlic 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. Placebo Comparator: Placebo 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	18
Estimated Completion Date	September 2008
Estimated Primary Completion Date	Not Provided
Eligibility 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
Gender	Both
Ages	21 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00499460
Other Study ID Numbers	2040.00
Has Data Monitoring Committee	No
Information Provided By	Fred Hutchinson Cancer Research Center
Study Sponsor	Fred Hutchinson Cancer Research Center
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: Danny Shen, PhD Fred Hutchinson Cancer Research Center
Verification Date	April 2012

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