Investigation of Kava Effects on NNK Metabolism

NCT ID: NCT02500472

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-03
• Study Completion Date: 2018-03-31

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.

Conditions

Tobacco Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Kava Supplement

See intervention description.

Group Type: EXPERIMENTAL

Kava

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Kava

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Fujioka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Wang Y, Fujioka N, Xing C. Quantitative profiling of cortisol metabolites in human urine by high-resolution accurate-mass MS. Bioanalysis. 2018 Dec;10(24):2015-2026. doi: 10.4155/bio-2018-0182. Epub 2018 Nov 6.

Reference Type: DERIVED

PMID: 30412681 (View on PubMed)

Other Identifiers

2015NTLS038

Identifier Type: -

Identifier Source: org_study_id