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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

Tracking Information
First Submitted Date  ICMJE June 26, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date April 4, 2018
Actual Study Start Date  ICMJE December 3, 2015
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02500472 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Percentage of subjects experiencing any particular adverse event [ Time Frame: Day 4 ]
    Determine the safety of short-term kava administration in healthy smokers
  • Percentage of subjects experiencing any particular adverse event [ Time Frame: Day 7 ]
    Determine the safety of short-term kava administration in healthy smokers
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Kava Effects on NNK Metabolism
Official Title  ICMJE Investigation of Kava Effects on the Metabolism of the Tobacco-specific Carcinogen 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Humans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Smoking
Intervention  ICMJE 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.
Study Arms Experimental: Kava Supplement
See intervention description.
Intervention: Dietary Supplement: Kava
Publications * Wang Y, Fujioka N, Xing C. Quantitative profiling of cortisol metabolites in human urine by high-resolution accurate-mass MS. Bioanalysis. 2018 Dec;10(24):2015-2026. doi: 10.4155/bio-2018-0182. Epub 2018 Nov 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
20
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500472
Other Study ID Numbers  ICMJE 2015NTLS038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Naomi Fujioka, MD University of Minnesota - Clinical and Translational Science Institute
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP