Effect of Garlic Supplements on Opioids in Healthy Volunteers
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00499460
First received: July 10, 2007
Last updated: April 30, 2012
Last verified: April 2012
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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 | Intervention | Phase |
|---|---|---|
|
Healthy, no Evidence of Disease |
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Modulation of Opioid Effects by Garlic Supplements |
Resource links provided by NLM:
Further study details as provided by Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
- Oxycodone hydrochloride pharmacodynamic measures
Secondary Outcome Measures:
- Oxycodone hydrochloride pharmacokinetic parameters
| Enrollment: | 18 |
| Study Start Date: | November 2006 |
| Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 |
|
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.
|
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 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499460
Locations
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
| Principal Investigator: | Danny Shen, PhD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Danny Shen, MD, FHCRC |
| ClinicalTrials.gov Identifier: | NCT00499460 History of Changes |
| Other Study ID Numbers: | 2040.00, IR-6130, CDR0000551927 |
| Study First Received: | July 10, 2007 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
healthy, no evidence of disease |
Additional relevant MeSH terms:
|
Digoxin Midazolam Oxycodone Analgesics, Opioid Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Protective Agents Physiological Effects of Drugs Adjuvants, Anesthesia Central Nervous System Agents |
Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013