This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess whether kava can alter NNK metabolism in humans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
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.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
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
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
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
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
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
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
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
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Time frame: Day 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 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 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
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
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
Percentage of subjects experiencing any particular adverse event
Determine the safety of short-term kava administration in healthy smokers
Time frame: Day 4
Percentage of subjects experiencing any particular adverse event
Determine the safety of short-term kava administration in healthy smokers
Time frame: Day 7
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
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