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CompletedNCT02500472Updated Apr 4, 2018

Investigation of Kava Effects on NNK Metabolism

An interventional study of Kava in Tobacco Smoking, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tobacco Smoking

Keywords

  • Tobacco
  • Smoking
03

In context

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Kava Supplement

    See intervention description.

    Dietary Supplement: Kava

Interventions

  • Dietary supplementKava

    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.

06

What researchers measure

Primary outcomes

  1. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

    Compare urinary level of total NNAL before and after short-term kava administration

    Time frame: Day 1

  2. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

    Compare urinary level of total NNAL before and after short-term kava administration

    Time frame: Day 2

  3. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

    Compare urinary level of total NNAL before and after short-term kava administration

    Time frame: Day 4

  4. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

    Compare urinary level of total NNAL before and after short-term kava administration

    Time frame: Day 5

  5. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

    Compare urinary level of total NNAL before and after short-term kava administration

    Time frame: Day 6

  6. Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

    Compare urinary level of total NNAL before and after short-term kava administration

    Time frame: Day 7

Secondary outcomes

  1. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

    Time frame: Day 1

  2. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

    Time frame: Day 2

  3. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

    Time frame: Day 4

  4. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

    Time frame: Day 5

  5. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

    Time frame: Day 6

  6. Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

    Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration

    Time frame: Day 7

  7. Percentage of subjects experiencing any particular adverse event

    Determine the safety of short-term kava administration in healthy smokers

    Time frame: Day 4

  8. Percentage of subjects experiencing any particular adverse event

    Determine the safety of short-term kava administration in healthy smokers

    Time frame: Day 7

  9. O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration

    Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration

    Time frame: Day 4

  10. O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration

    Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration

    Time frame: Day 7

07

Study locations

1 site
  • Masonic Cancer Center, University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

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. PubMed 30412681 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02500472
Lead sponsor
Masonic Cancer Center, University of Minnesota
Responsible party
Sponsor
First posted
Jul 16, 2015
Start date
Dec 3, 2015
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Apr 4, 2018

Study contacts

Naomi Fujioka, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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