- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02500472
Investigation of Kava Effects on NNK Metabolism
April 2, 2018 updated by: Masonic Cancer Center, University of Minnesota
Investigation of Kava Effects on the Metabolism of the Tobacco-specific Carcinogen 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Humans
This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess whether kava can alter NNK metabolism in humans.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center, University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kava Supplement
See intervention description.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
Time Frame: Day 1
|
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
Time Frame: Day 2
|
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
Time Frame: Day 4
|
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
Time Frame: Day 5
|
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
Time Frame: Day 6
|
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
Time Frame: Day 7
|
Compare urinary level of total NNAL before and after short-term kava administration
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time Frame: Day 1
|
Compare the ratio of urinary NNAL-gluc and free NNAL 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
Time Frame: Day 2
|
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
|
Day 2
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Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time Frame: Day 4
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Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
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Day 4
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Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time Frame: Day 5
|
Compare the ratio of urinary NNAL-gluc and free NNAL 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
Time Frame: Day 6
|
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
|
Day 6
|
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time Frame: Day 7
|
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
|
Day 7
|
Percentage of subjects experiencing any particular adverse event
Time Frame: Day 4
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Determine the safety of short-term kava administration in healthy smokers
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Day 4
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Percentage of subjects experiencing any particular adverse event
Time Frame: Day 7
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Determine the safety of short-term kava administration in healthy smokers
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Day 7
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O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration
Time Frame: Day 4
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Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration
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Day 4
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O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration
Time Frame: Day 7
|
Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration
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Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2015
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
June 26, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 16, 2015
Study Record Updates
Last Update Posted (Actual)
April 4, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
December 1, 2017
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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