Tobacco Smoking
Conditions
Keywords
Tobacco, Smoking
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.
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.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary level (nmol/mL) of total NNAL before and after short-term kava administration | Day 1 | Compare urinary level of total NNAL before and after short-term kava administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration | Day 1 | 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 | Day 4 | 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 | Day 4 | Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration |
Countries
United States
Outcome results
None listed