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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05081882
• Other study ID #: Kava
• Secondary ID: OCR40933IRB20210
• Status: Recruiting
• Phase: Phase 2
• Start date: June 9, 2022
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: Melissa Malham
• Phone: (352) 294-5892
• Email: UF-KavaStudy[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

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.
• Placebo
Participants on this arm will take one placebo capsule orally three times daily for 28 days.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Compliance with Intervention	Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses	4 weeks
Primary	Subject Compliance with Intervention	Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine	4 weeks
Secondary	Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked	12 weeks
Secondary	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
Secondary	Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)	12 weeks
Secondary	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
Secondary	Tobacco cessation	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents	12 weeks