Investigation of Kava Effects on NNK Metabolism

Completed · Not applicable

Conditions studied: Tobacco Smoking

In brief

This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess whether kava can alter NNK metabolism in humans.

Key facts

Study ID

NCT02500472

Run by

Masonic Cancer Center, University of Minnesota

People needed

24

Starts

2015-12-03

Expected to finish

2018-03-01

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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