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Investigation of Kava Effects on NNK Metabolism

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ClinicalTrials.gov Identifier: NCT02500472
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess whether kava can alter NNK metabolism in humans.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Dietary Supplement: Kava Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Kava Effects on the Metabolism of the Tobacco-specific Carcinogen 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Humans
Actual Study Start Date : December 3, 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: Kava Supplement
See intervention description.
Dietary Supplement: Kava
3 doses equaling 250 mg kavalactones per day. Participants will take 1 capsule three times daily at 8:00 (± 2 hours), 14:00 (± 2 hours) and 20:00 (± 2 hours) for 7 consecutive days.




Primary Outcome Measures :
  1. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration [ Time Frame: Day 1 ]
    Compare urinary level of total NNAL before and after short-term kava administration

  2. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration [ Time Frame: Day 2 ]
    Compare urinary level of total NNAL before and after short-term kava administration

  3. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration [ Time Frame: Day 4 ]
    Compare urinary level of total NNAL before and after short-term kava administration

  4. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration [ Time Frame: Day 5 ]
    Compare urinary level of total NNAL before and after short-term kava administration

  5. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration [ Time Frame: Day 6 ]
    Compare urinary level of total NNAL before and after short-term kava administration

  6. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration [ Time Frame: Day 7 ]
    Compare urinary level of total NNAL before and after short-term kava administration


Secondary Outcome Measures :
  1. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration [ Time Frame: Day 1 ]
    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

  2. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration [ Time Frame: Day 2 ]
    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

  3. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration [ Time Frame: Day 4 ]
    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

  4. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration [ Time Frame: Day 5 ]
    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

  5. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration [ Time Frame: Day 6 ]
    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

  6. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration [ Time Frame: Day 7 ]
    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

  7. Percentage of subjects experiencing any particular adverse event [ Time Frame: Day 4 ]
    Determine the safety of short-term kava administration in healthy smokers

  8. Percentage of subjects experiencing any particular adverse event [ Time Frame: Day 7 ]
    Determine the safety of short-term kava administration in healthy smokers

  9. O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration [ Time Frame: Day 4 ]
    Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration

  10. O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration [ Time Frame: Day 7 ]
    Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult ≥ 18 years
  • Current smoker of ≥ 5 cigarettes daily, determined by self-report
  • Adequate liver and kidney function, defined as:

    • Bilirubin, alkaline phosphatase, ALT, and AST within normal limits
    • Creatinine <1.2
  • Adequate hemoglobin, defined as a hemoglobin ≥12 mg/dL for men and ≥11 for women.
  • Ability and willingness to abstain from all medication and dietary supplements for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration. Topical medications and inhaled medications that do not contain steroids are permitted.
  • Ability and willingness to completely abstain from alcohol consumption for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration
  • Ability to understand the investigational nature of the study and provide informed consent
  • Willingness to take kava supplement as instructed

Exclusion Criteria:

  • Known hepatobiliary disease or impairment
  • History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect the absorption of kava
  • Chronic medication use that cannot be safely stopped
  • Use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes)
  • Major or chronic medical medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
  • Women who are pregnant, intend to become pregnant within 3 months of the study period, or who are breastfeeding
  • Current or recent (within 12 months) problems with drug use or alcohol dependence by self-report
  • Antibiotic use within 2 months of study enrollment by self-report
  • Alcohol dependence, abuse, or history of dependence/abuse by self-report

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500472


Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Naomi Fujioka, MD University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT02500472     History of Changes
Other Study ID Numbers: 2015NTLS038
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: December 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
Tobacco
Smoking