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Modulation of Opioid Effects by Garlic Supplements


Phase 4
21 Years
45 Years
Not Enrolling
Both
Healthy, no Evidence of Disease

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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 CenterSeattle, Washington  98109