Recruiting
Phase 2

Kava

Sponsor:

University of Florida

Code:

NCT05814055

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

AB-free kava

Study Details

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.

Conditions

Smoking

Study ID

NCT05814055

Start date

Jun 6, 2024

Status verified date

Dec, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: AB-free kava

placebo comparator: Placebo control

Interventions

Placebo

Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.

AB-free kava

Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.

Primary outcome measure

  • Subject Compliance with Intervention [ Time Frame: 4 weeks ]
  • Subject Compliance with Intervention [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Ramzi G Dr. Salloum

352-294-4997rsalloum@ufl.edu

Chengguo Dr. Xing

352-294-8511chengguoxing@cop.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Melissa Malham

352-294-5892UF-KavaStudy@ufl.edu

Principal Investigator:

Ramzi Salloum, PhD

More Information

Sponsor

University of Florida

Last update posted

Jan 27, 2026

Last verified

Dec, 2025

Keywords

  • kava
  • smoking cessation
  • tobacco dependence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-01-27.