Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Minneapolis, Minnesota 55455


Purpose:

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


Criteria:

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


NCT ID:

NCT02500472


Primary Contact:

Principal Investigator
Naomi Fujioka, MD
University of Minnesota - Clinical and Translational Science Institute


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.