Actively Recruiting
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
Led by University of Florida · Updated on 2026-01-27
76
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years or above up to 75 years old
- Self-reported smoking at least 5 cigarettes per day for the past year with intention to quit at screening
- Expired carbon monoxide level greater than 8 ppm at recruitment
- Willingness to participate with signed informed consent
- Access to a functional telephone
- Expected to remain in the study's geographical area for the next 4 months
- Not currently enrolled in any smoking cessation programs by self-report
- Female participants of childbearing potential must use acceptable birth control methods
- If previously taking kava supplements, a 2-week washout period is required before starting the study
You will not qualify if you...
- History of active cancer (other than non-melanoma skin cancer) within the past 2 years
- Diagnosed liver dysfunction or previous liver diseases
- Elevated liver enzymes or bilirubin above normal limits at prescreening
- Unable to avoid acetaminophen, alcohol (more than one drink daily), or other potentially liver-toxic substances
- Pregnant, nursing, or planning pregnancy without adequate contraception during the study
- Positive answers to the first three Modified Ask Suicide Screening Questions or refusal to answer these questions
- Recent suicide attempt within 12 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
R
Ramzi G Dr. Salloum
CONTACT
C
Chengguo Dr. Xing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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