Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava

Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians.

This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.

Study Overview

• Status: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Drug: Kava; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Melissa Malham; Phone Number: (352) 294-5892; Email: UF-KavaStudy@ufl.edu
• Study Contact Backup: Name: Nicole Davila; Phone Number: (352) 273-7345; Email: UF-KavaStudy@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida
      • Principal Investigator: Ramzi Salloum, PhD
      • Contact: Melissa Malham; Phone Number: 352-294-5892; Email: UF-KavaStudy@ufl.edu
      • Contact: Nicole Davila; Phone Number: (352) 273-7345; Email: UF-KavaStudy@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults aged 21 years or above
• self-reported smoking at least 10 cigarette/day for the past year with no intention to quit
• expired carbon monoxide level of more than 8 ppm at recruitment
• willingness to participate in the proposed study
• 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
• 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, Intrauterine Device [IUD], Diaphragm, and cervical cap)

Exclusion Criteria:

• diagnosed with cancer (other than non-melanoma skin cancer)
• diagnosed with liver dysfunction or with previous liver diseases
• levels of alanine transaminase, aspartate transaminase, alkaline phosphatase, or total bilirubin over limit of normal range at prescreen
• inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances
• use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes
• 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 ASQ questions 1 through 4, or refuses to answer. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control	Drug: Placebo; Participants on this arm will take one placebo capsule orally three times daily for 28 days.
Experimental: Kava Intervention	Drug: Kava; Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked	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)	12 weeks
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)	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)	12 weeks
Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents	12 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Ramzi Salloum, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: smoking cessation; tobacco dependence; kava
• Other Study ID Numbers: Kava; OCR40933 (Other Identifier: University of Florida); IRB202101885 (Other Identifier: University of Florida IRB-01)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No