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Effects of Garlic Supplements on Opioids in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Danny Shen, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00499460
First received: July 10, 2007
Last updated: April 5, 2017
Last verified: April 2017
Results First Received: February 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant;   Primary Purpose: Basic Science
Condition: Healthy, No Evidence of Disease
Interventions: Dietary Supplement: garlic powder tablets
Drug: oxycodone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was between November 2006 and August 2008. Healthy subjects were recruited from the University of Washington and Fred Hutchinson Cancer Research Center campuses through public notices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Garlic First, Then Placebo Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
Placebo First, Then Garlic Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.

Participant Flow for 2 periods

Period 1:   Intervention 1 (30 Days)
    Garlic First, Then Placebo   Placebo First, Then Garlic
STARTED   8   7 
COMPLETED   6   7 
NOT COMPLETED   2   0 
Withdrawal by Subject                1                0 
Fainting upon Blood Draw                1                0 

Period 2:   Intervention 2 (30 Days)
    Garlic First, Then Placebo   Placebo First, Then Garlic
STARTED   6   7 
COMPLETED   6   6 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 15 enrollees, 6 subjects completed the study protocol in each assigned arm; hence, baseline analysis is only available in those 12 subjects.

Reporting Groups
  Description
Garlic First, Then Placebo Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
Placebo First, Then Garlic Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
Total Total of all reporting groups

Baseline Measures
   Garlic First, Then Placebo   Placebo First, Then Garlic   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.3  (5.2)   30.5  (6.0)   29.9  (5.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  50.0%      3  50.0%      6  50.0% 
Male      3  50.0%      3  50.0%      6  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1  16.7%      0   0.0%      1   8.3% 
Not Hispanic or Latino      5  83.3%      6 100.0%      11  91.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1  16.7%      1   8.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      6 100.0%      5  83.3%      11  91.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   6   6   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Oxycodone Oral Clearance   [ Time Frame: Serial blood sampling over 24 hours after a 15-mg oral dose of oxycodone ]

2.  Secondary:   Cold Pressor Tolerance AUC   [ Time Frame: 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 ]

3.  Secondary:   Somatic Side Effects Total Score   [ Time Frame: SSE scores at 150 min after a single 15-mg oral dose of oxycodone ]

4.  Secondary:   Cognitive-Affective Side Effects Total Score   [ Time Frame: CASE scores at 150 min after a single 15-mg oral dose of oxycodone ]

5.  Secondary:   Oral Midazolam Test   [ Time Frame: Serial blood sampling over 6 hours after a 5-mg oral test dose of midazolam ]

6.  Secondary:   Oral Digoxin Test   [ Time Frame: Serial blood sampling over 4 hours after a 0.5-mg oral test dose of digoxin ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Danny D. Shen, Member (Retired)
Organization: Clinical Research Division, Fred Hutchinson Cancer Research Center
phone: 206-685-2920
e-mail: ds@uw.edu



Responsible Party: Danny Shen, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00499460     History of Changes
Other Study ID Numbers: 2040.00
IR-6130 ( Other Identifier: FHCRC IRB )
CDR0000551927 ( Other Identifier: PDQ )
R21CA118334 ( US NIH Grant/Contract Award Number )
Study First Received: July 10, 2007
Results First Received: February 7, 2017
Last Updated: April 5, 2017