Investigation of Kava Effects on NNK Metabolism

NCT02500472 | Completed DMC

• 1 other identifier: 2015NTLS038
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Tobacco; Smoking

Outcome Measures

Primary Outcomes (6)

• Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

  Compare urinary level of total NNAL before and after short-term kava administration

  Day 1

• Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

  Compare urinary level of total NNAL before and after short-term kava administration

  Day 2

• Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

  Compare urinary level of total NNAL before and after short-term kava administration

  Day 4

• Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

  Compare urinary level of total NNAL before and after short-term kava administration

  Day 5

• Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

  Compare urinary level of total NNAL before and after short-term kava administration

  Day 6

• Urinary level (nmol/mL) of total NNAL before and after short-term kava administration

  Compare urinary level of total NNAL before and after short-term kava administration

  Day 7

Secondary Outcomes (10)

• Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

  Day 1

• Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

  Day 2

• Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

  Day 4

• Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

  Day 5

• Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration

  Day 6

Study Arms (1)

Kava Supplement

EXPERIMENTAL

See intervention description.

Dietary Supplement: Kava

Interventions

Kava 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.

Kava Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 30412681 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Study Officials

• Naomi Fujioka, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 16, 2015
• Study Start: December 3, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 4, 2018

Record last verified: 2017-12

Locations

US (1)