Effects of Garlic Supplements on Opioids in Healthy Volunteers

NCT00499460 | Completed Phase 4 Results FDA Drug

• 4 other identifiers: 2040.00IR-6130CDR0000551927R21CA118334
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy, No Evidence of Disease

Keywords

Healthy, No Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Oxycodone Oral Clearance

  Oxycodone oral clearance is computed by Dose/AUC, where AUC is the area under the plasma oxycodone concentration-time curve from time zero to infinity. Oral clearance is a measure of the rate at which oxycodone is cleared from the body via metabolism.

  Serial blood sampling over 24 hours after a 15-mg oral dose of oxycodone

Secondary Outcomes (5)

• Cold Pressor Tolerance AUC

  Repeated testing for tolerance to Cold Pressor Test just before and at 45, 90, 150 and 300 min after a single 15-mg oral dose of oxycodone

• Somatic Side Effects Total Score

  SSE scores at 150 min after a single 15-mg oral dose of oxycodone

• Cognitive-Affective Side Effects Total Score

  CASE scores at 150 min after a single 15-mg oral dose of oxycodone

• Oral Midazolam Test

  Serial blood sampling over 6 hours after a 5-mg oral test dose of midazolam

• Oral Digoxin Test

  Serial blood sampling over 4 hours after a 0.5-mg oral test dose of digoxin

Study Arms (2)

Arm I

OTHER

Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder tablet twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29.

Dietary Supplement: garlic powder tablets; Drug: oxycodone

Arm II

OTHER

Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder tablet twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29.

Dietary Supplement: garlic powder tablets; Drug: oxycodone

Interventions

garlic powder tablets DIETARY_SUPPLEMENT

Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet

Also known as: Nature's Way Garlicin

Arm I; Arm II

oxycodone DRUG

Single administration of three 5-mg oxycodone tablets or a 15-mg dose

Also known as: oxycodone hydrochoride, Roxicodone

Arm I; Arm II

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer
• Body mass index 20-32

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Danny D. Shen, Member (Retired)
• Organization: Clinical Research Division, Fred Hutchinson Cancer Research Center

ds@uw.edu

206-685-2920

Study Officials

• Danny D Shen, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)