SmokingPhase 2NCT05814055
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
A Phase 2 study testing AB-free kava in people with Smoking, run by University of Florida at 1 site in United States.
Trial summary
This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Smoking
- What is being tested?
- AB-free kava
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 21 years or above (legal age for smoking in the U.S.) up to 75 years old;
- self-reported smoking at least 5 cigarettes/day for the past year with INTENTION to quit at time of screening visit;
- expired carbon monoxide level of more than 8 ppm at recruitment;
- willingness to participate in the proposed study, as indicated by signed informed consent;
- access to a functional telephone;
- expected presence in the study's geographical area for the next 4 months;
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- not currently enrolled in any smoking cessation programs per self report; and
- female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, IUD, Diaphragm, and cervical cap).
- if a participant takes kava dietary supplement, a 2-week washout period is needed for the participant to initiate this study or if a participant participated in a kava trial before, such as the kava JEK trial, the participant could be enrolled if the inclusion criteria above are met, including the 2-week washout period.
Who cannot join
- history of active cancer (other than non-melanoma skin cancer) within the past 2 years;
- diagnosed with liver dysfunction or with previous liver diseases;
- levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
- inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
- are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
- participant answered "Yes" to any of the Modified Ask Suicide Screening Questions questions 1 through 3, or refuses to answer all of the questions. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place >12 months from screening visit then subject is still eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Melissa Malham, 352-294-5892, UF-KavaStudy@ufl.edu
Ramzi Salloum, PhD
About this study
This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.
- Conditions
- Smoking
- Being tested
- Placebo, AB-free kava
- Keywords
- kava, smoking cessation, tobacco dependence
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
AB-free kavaDrug
Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AB-free kava | Experimental | Not described Receives: Drug: AB-free kava |
| Placebo control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Compliance with Intervention
Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
Measured: 4 weeks
Subject Compliance with Intervention
Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing
Measured: 4 weeks
Secondary outcomes (15)
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked
Measured: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)
Measured: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)
Measured: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)
Measured: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents
Measured: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by the Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 40 and the minimum score is 0. A higher score indicates greater perceived stress.
Measured: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA
Measured: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by plasma cortisol
Measured: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by urinary TCE
Measured: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents
Measured: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by the Insomnia Severity Scale. The Insomnia Severity Scale instrument consists of 7 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 28 and the minimum score is 0. A higher score indicates more severe insomnia.
Measured: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)
Measured: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin
Measured: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin
Measured: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by urinary NAS
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start6 Jun 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 SmokingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ramzi Salloum, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814055
- Sponsor's protocol ID
- Kava 2
- Other IDs
- OCR44061, IRB202300887, 1R33AT012328-01
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Xing C, Malaty J, Malham MB, Orlando FA, Lynch A, Huo Z, Francois M, Firpi-Morell R, Fisher CL, Christou DD, Salloum RG. The potential of AB-free kava in enabling tobacco cessation via management of abstinence-related stress and insomnia: study protocol for a randomized clinical trial. BMC Complement Med Ther. 2024 Dec 21;24(1):422. doi: 10.1186/s12906-024-04722-9.
PubMed 39709468
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
- ClinicalTrials.gov ID
- NCT05814055
- Acronym / sponsor ID
- Kava 2
- Conditions
- Smoking
- Keywords
- kava, smoking cessation, tobacco dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Apr 2023 (actual)
- 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 study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB-free kava | Experimental | Drug: AB-free kava |
| Placebo control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- adults aged 21 years or above (legal age for smoking in the U.S.) up to 75 years old;
- self-reported smoking at least 5 cigarettes/day for the past year with INTENTION to quit at time of screening visit;
- expired carbon monoxide level of more than 8 ppm at recruitment;
- willingness to participate in the proposed study, as indicated by signed informed consent;
- access to a functional telephone;
Key exclusion criteria (6 listed)
- history of active cancer (other than non-melanoma skin cancer) within the past 2 years;
- diagnosed with liver dysfunction or with previous liver diseases;
- levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
- inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
- are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
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 |
|---|---|---|
| PlaceboParticipants on this arm will take one placebo capsule orally three times daily for 4 weeks. | Drug | Placebo control |
| AB-free kavaParticipants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks. | Drug | AB-free kava |
Primary outcome
Subject Compliance with Intervention
Time frame: 4 weeks
Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
Subject Compliance with Intervention
Time frame: 4 weeks
Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing
15 secondary outcomes
Tobacco cessation
Time frame: 12 weeks
Tobacco cessation
Time frame: 12 weeks
Tobacco cessation
Time frame: 12 weeks
Tobacco cessation
Time frame: 12 weeks
Tobacco cessation
Time frame: 12 weeks
Effect on stress
Time frame: 12 weeks
Effect on stress
Time frame: 12 weeks
Effect on stress
Time frame: 12 weeks
Effect on stress
Time frame: 12 weeks
Effect on stress
Time frame: 12 weeks
Effect on sleep
Time frame: 12 weeks
Effect on sleep
Time frame: 12 weeks
Effect on sleep
Time frame: 12 weeks
Effect on sleep
Time frame: 12 weeks
Effect on sleep
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Derived from this study: PubMed 39709468Xing C, Malaty J, Malham MB, Orlando FA, Lynch A, Huo Z, Francois M, Firpi-Morell R, Fisher CL, Christou DD, Salloum RG. The potential of AB-free kava in enabling tobacco cessation via management of abstinence-related stress and insomnia: study protocol for a randomized clinical trial. BMC Complement Med Ther. 2024 Dec 21;24(1):422. doi: 10.1186/s12906-024-04722-9.
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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.
Ramzi Salloum, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AB-free kava in people with Smoking, run by University of Florida 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramzi G Dr. Salloum (352-294-4997, rsalloum@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Compliance with Intervention (time frame: 4 weeks). The study lists 2 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 NCT05814055, 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 27 Jan 2026.