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Kava for Smoking Cessation

Phase 2
Recruiting
Led By Ramzi Salloum, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged 21 years or above (legal age for smoking in the U.S.)
Be older than 18 years old
Must not have
Diagnosed with liver dysfunction or with previous liver diseases
Diagnosed with cancer (other than non-melanoma skin cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trial will look at how well smokers follow a daily kava routine and whether using kava can help them quit smoking, reduce stress, and sleep better.

Who is the study for?
This trial is for adults over 21 who smoke at least 10 cigarettes a day, want to quit, and have high carbon monoxide levels from smoking. They must live in the study area for 4 months, not be in other quit programs, and if they can become pregnant, use reliable birth control.
What is being tested?
The study tests if kava helps smokers quit by reducing stress and improving sleep. Participants will follow a daily kava regimen or take a placebo without knowing which one they're getting to compare the effects on quitting success.
What are the potential side effects?
Kava may cause side effects like digestive issues (upset stomach), dizziness, skin changes (rash), liver damage with heavy use, but it's generally considered safe when used short-term under supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have liver problems or a history of liver disease.
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I have been diagnosed with a type of cancer other than non-melanoma skin cancer.
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I cannot avoid taking acetaminophen, drinking more than one alcoholic drink a day, or using substances that may harm my liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subject Compliance with Intervention
Secondary study objectives
Effect on sleep
Effect on stress
Tobacco cessation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AB-free kavaExperimental Treatment1 Intervention
Group II: Placebo controlPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,400 Previous Clinical Trials
767,033 Total Patients Enrolled
2 Trials studying Smoking
124 Patients Enrolled for Smoking
National Center for Complementary and Integrative Health (NCCIH)NIH
854 Previous Clinical Trials
671,664 Total Patients Enrolled
3 Trials studying Smoking
7,260 Patients Enrolled for Smoking
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,535 Total Patients Enrolled
38 Trials studying Smoking
17,648 Patients Enrolled for Smoking
~51 spots leftby Jun 2026
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