Investigation of Kava Effects on NNK Metabolism

Not Applicable

Completed

• Conditions: Tobacco Smoking
• Interventions: Dietary Supplement: Kava

• Registration Number: NCT02500472
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2015-12-03
• Status Verified: 2017-12
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kava Supplement	Kava	See intervention description.

Primary Outcome Measures

Name	Time	Method
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration	Day 7	Compare urinary level of total NNAL before and after short-term kava administration

Secondary Outcome Measures

Name	Time	Method
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration	Day 7	Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration	Day 7	Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration
Percentage of subjects experiencing any particular adverse event	Day 7	Determine the safety of short-term kava administration in healthy smokers

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States