~44 spots leftby Jun 2026

Kava for Smoking Cessation

RS
Overseen byRamzi Salloum, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Florida
Must not be taking: Acetaminophen, Alcohol
Disqualifiers: Cancer, Liver dysfunction, Pregnancy, others
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking a kava dietary supplement, you will need to stop for a 2-week period before starting the study.

Is kava safe for human use?

Kava has been used for its calming effects, but there are concerns about its safety, particularly regarding liver damage. While most side effects are mild and rare, serious liver-related issues have been reported, so it's important to use kava cautiously and under guidance.12345

How does the treatment Kava differ from other smoking cessation treatments?

Kava is unique as a smoking cessation treatment because it is a herbal product, which is a type of complementary and alternative medicine (CAM). Unlike nicotine replacement therapies like patches or gum, Kava may appeal to those interested in herbal and natural remedies, although its effectiveness for smoking cessation is not well-documented.678910

Research Team

RS

Ramzi Salloum, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

I am willing to participate in this study.
Access to a functional telephone
Not currently enrolled in any smoking cessation programs
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Exclusion Criteria

Levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen
I have liver problems or a history of liver disease.
Use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes
See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily kava regimen to evaluate compliance and its effects on tobacco cessation, stress, and sleep

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Kava (Herbal Supplement)
  • Placebo (Placebo)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AB-free kavaExperimental Treatment1 Intervention
Group II: Placebo controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+
Dr. Stephen J. Motew profile image

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey profile image

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Dr. Amy P. Patterson

National Center for Complementary and Integrative Health (NCCIH)

Chief Medical Officer

MD from Johns Hopkins University

Dr. Helene Langevin profile image

Dr. Helene Langevin

National Center for Complementary and Integrative Health (NCCIH)

Chief Executive Officer since 2018

MD from McGill University

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+
Dr. Jeanne Marrazzo profile image

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya profile image

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

In an 8-week clinical trial with 129 outpatients, Kava-Kava LI 150 was found to be as effective as Buspirone and Opipramol for treating Generalized Anxiety Disorder, with about 75% of patients responding positively to treatment.
Kava-Kava LI 150 was well tolerated, showing no significant safety concerns compared to the other medications, indicating it could be a viable alternative for anxiety treatment.
Kava-Kava extract LI 150 is as effective as Opipramol and Buspirone in Generalised Anxiety Disorder--an 8-week randomized, double-blind multi-centre clinical trial in 129 out-patients.Boerner, RJ., Sommer, H., Berger, W., et al.[2019]
27% of tobacco users at a specialty clinic reported having previously used complementary and alternative medicine (CAM) for quitting, with hypnosis, relaxation, acupuncture, and meditation being the most common methods.
A significant 67% of participants expressed interest in using CAM for tobacco cessation in the future, particularly in hypnosis, herbal products, and acupuncture, highlighting a strong demand for further research in this area.
Complementary treatments for tobacco cessation: a survey.Sood, A., Ebbert, JO., Sood, R., et al.[2022]
Intensive multicomponent behavioral interventions can lead to long-term smoking cessation rates of nearly 50%, highlighting their effectiveness compared to other methods.
Nicotine replacement therapies, such as gum and patches, significantly enhance smoking cessation outcomes, with patches being easier for patients to use correctly.
Smoking cessation products and programs.Lando, HA.[2007]

References

Measuring the chemical and cytotoxic variability of commercially available kava (Piper methysticum G. Forster). [2021]
Kava-Kava extract LI 150 is as effective as Opipramol and Buspirone in Generalised Anxiety Disorder--an 8-week randomized, double-blind multi-centre clinical trial in 129 out-patients. [2019]
An Updated Review on the Psychoactive, Toxic and Anticancer Properties of Kava. [2022]
A systematic review of the safety of kava extract in the treatment of anxiety. [2018]
Kava as a Clinical Nutrient: Promises and Challenges. [2021]
Complementary treatments for tobacco cessation: a survey. [2022]
Smoking cessation products and programs. [2007]
Meta-analysis of studies investigating one-year effectiveness of transdermal nicotine patches for smoking cessation. [2019]
Alternative smoking cessation aids: a meta-analysis of randomized controlled trials. [2019]
Three year continuous abstinence in a smoking cessation study using the nicotine transdermal patch. [2019]