NCT05814055 The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
| NCT ID | NCT05814055 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Florida |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2024-06-06 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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.
Contact & Investigator
Ramzi Salloum, PhD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05814055 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05814055 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05814055 currently recruiting?
Yes, NCT05814055 is actively recruiting participants. Contact the research team at rsalloum@ufl.edu for enrollment information.
Where is the NCT05814055 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05814055 clinical trial?
NCT05814055 is sponsored by University of Florida. The principal investigator is Ramzi Salloum, PhD at University of Florida. The trial plans to enroll 76 participants.