The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence

Phase 2

Recruiting

• Conditions: Smoking
• Interventions: Drug: AB-free kava; Drug: Placebo

• Registration Number: NCT05814055
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Study Start: 2024-06-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• adults aged 21 years or above (legal age for smoking in the U.S.) up to 99 years old;
• self-reported smoking at least 10 cigarette/day for the past year with 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; 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

• 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 (ULN) 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; or
• 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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AB-free kava	AB-free kava	-
Placebo control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Subject Compliance with Intervention	4 weeks	Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing

Secondary Outcome Measures

Name	Time	Method
Tobacco cessation	12 weeks	Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents
Effect on stress	12 weeks	Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents
Effect on sleep	12 weeks	Examine whether kava has the potential to improve sleep, as measured by urinary NAS

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States