Tobacco SmokingNCT02500472
Investigation of Kava Effects on NNK Metabolism
A study testing Kava in people with Tobacco Smoking, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Kava
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
- Conditions
- Tobacco Smoking
- Being tested
- Kava
- Keywords
- Tobacco, Smoking
- Medical subject headings
- Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KavaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Kava Supplement | Experimental | See intervention description. Receives: Dietary Supplement: Kava |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 7
Secondary outcomes (10)
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
Measured: Day 1
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
Measured: Day 2
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
Measured: Day 4
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
Measured: Day 5
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
Measured: Day 6
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Compare the ratio of urinary NNAL-gluc and free NNAL before and after short-term kava administration
Measured: Day 7
Percentage of subjects experiencing any particular adverse event
Determine the safety of short-term kava administration in healthy smokers
Measured: Day 4
Percentage of subjects experiencing any particular adverse event
Determine the safety of short-term kava administration in healthy smokers
Measured: Day 7
O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration
Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration
Measured: Day 4
O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration
Quantify O6-mG adducts in peripheral blood cells before and after short-term kava administration
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start3 Dec 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Fujioka, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500472
- Sponsor's protocol ID
- 2015NTLS038
- Status last verified
- Dec 2017
- First submitted
- 26 Jun 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30412681
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Kava Effects on the Metabolism of the Tobacco-specific Carcinogen 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Humans
- ClinicalTrials.gov ID
- NCT02500472
- Acronym / sponsor ID
- 2015NTLS038
- Conditions
- Tobacco Smoking
- Keywords
- Tobacco, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kava Supplement | Experimental | Dietary Supplement: KavaSee intervention description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult ≥ 18 years
- Current smoker of ≥ 5 cigarettes daily, determined by self-report
- Adequate liver and kidney function, defined as:
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kava3 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. | Dietary supplement | Kava Supplement |
Primary outcome
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
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
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
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
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
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
10 secondary outcomes
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time frame: 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
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time frame: Day 4
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time frame: 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
Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration
Time frame: Day 7
Percentage of subjects experiencing any particular adverse event
Time frame: Day 4
Percentage of subjects experiencing any particular adverse event
Time frame: Day 7
O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration
Time frame: Day 4
O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Derived from this study: PubMed 30412681Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Fujioka, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kava in people with Tobacco Smoking, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02500472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.