NCT05814055

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
18mo left

Started Jun 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jun 2024Oct 2027

First Submitted

Initial submission to the registry

April 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 6, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

January 27, 2026

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

April 3, 2023

Last Update Submit

January 26, 2026

Conditions

Smoking

Keywords

kavasmoking cessationtobacco dependence

Outcome Measures

Primary Outcomes (2)

  • Subject Compliance with Intervention

    Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses

    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

    4 weeks

Secondary Outcomes (15)

  • Tobacco cessation

    12 weeks

  • Tobacco cessation

    12 weeks

  • Tobacco cessation

    12 weeks

  • Tobacco cessation

    12 weeks

  • Tobacco cessation

    12 weeks

  • +10 more secondary outcomes

Study Arms (2)

AB-free kava

EXPERIMENTAL
Drug: AB-free kava

Placebo control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

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

Placebo control
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.

AB-free kava

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39709468DERIVED

MeSH Terms

Conditions

SmokingSmoking CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ramzi Salloum, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramzi G Dr. Salloum

CONTACT

352-294-4997rsalloum@ufl.edu

Chengguo Dr. Xing

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 14, 2023

Study Start

June 6, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

January 27, 2026

Record last verified: 2025-12

Locations

US(1)