Kava for Smoking Cessation

Overseen By Chengguo Dr. Xing

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Acetaminophen, Alcohol

Disqualifiers: Cancer, Liver dysfunction, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

76 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

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

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

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
• Placebo

Trial Overview 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.

Participant Groups

Group I: AB-free kava Experimental Treatment 1 Intervention

Group II: Placebo control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A study of 25 commercially available kava products showed significant variability in their chemical composition and cytotoxic effects on human lung cancer cells, indicating that not all kava products are the same in terms of safety and efficacy.

Despite past concerns about kava's potential liver toxicity leading to restrictions, the demand for kava in the U.S. is rising, highlighting the need for more research to better understand its effects and ensure consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the chemical and cytotoxic variability of commercially available kava (Piper methysticum G. Forster). Martin, AC., Johnston, E., Xing, C., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Kava has been traditionally used in the South Pacific for its calming effects and is now recognized in Western countries as a natural treatment for anxiety, depression, and insomnia, but it carries risks of liver injury and other toxic effects, particularly with heavy use.

Research indicates that kava may have potential anticancer properties, showing effects like apoptosis and cell cycle arrest in various cancer models, although it has also been linked to carcinogenicity in animal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Updated Review on the Psychoactive, Toxic and Anticancer Properties of Kava. Soares, RB., Dinis-Oliveira, RJ., Oliveira, NG.[2022]

Kava extracts are generally well tolerated and associated with rare, mild, and reversible adverse events when used as a short-term treatment for anxiety, based on a systematic review of clinical evidence.

However, serious adverse events, including liver damage and neurological complications, have been reported, indicating the need for further research to better understand the risks associated with kava use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of kava extract in the treatment of anxiety. Stevinson, C., Huntley, A., Ernst, E.[2018]

Kava, derived from the root of Piper methysticum, has a long history of use for its neurological benefits and potential anti-inflammatory and anticancer effects, but it also poses risks of rare hepatotoxicity associated with certain preparations.

There is a significant need for standardization and quality control of kava products to ensure safety and efficacy, as well as to guide future research and clinical trials on its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kava as a Clinical Nutrient: Promises and Challenges. Bian, T., Corral, P., Wang, Y., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation products and programs. Lando, HA.[2007]

A meta-analysis of 16 randomized clinical trials involving 9,457 participants showed that transdermal nicotine patches significantly improve smoking cessation rates compared to placebo, with an odds ratio of 1.79 for one-year abstinence.

The effectiveness of nicotine patches was consistent across different measures of abstinence, indicating they are a reliable option for helping individuals quit smoking over a one-year period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of studies investigating one-year effectiveness of transdermal nicotine patches for smoking cessation. Myung, SK., Yoo, KY., Oh, SW., et al.[2019]

Acupuncture and hypnotherapy show promising efficacy for smoking cessation, with odds ratios of 3.53 and 4.55 respectively, based on a meta-analysis of 14 trials involving 1,195 participants.

Aversive smoking also appears to aid in quitting, with an odds ratio of 4.26, but lacks recent trials to support its effectiveness, highlighting the need for more research on alternative smoking cessation methods compared to standard pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative smoking cessation aids: a meta-analysis of randomized controlled trials. Tahiri, M., Mottillo, S., Joseph, L., et al.[2019]

In a study of 305 participants, those using a 24-hour transdermal nicotine patch alongside a cognitive-behavioral smoking cessation program had a continuous abstinence rate of 13.8% after three years, significantly higher than the 5.2% rate in the placebo group.

The combination of the active nicotine patch and behavioral therapy not only doubled the early abstinence rates but also maintained this advantage over the three-year follow-up period, highlighting the efficacy of this intervention for long-term smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three year continuous abstinence in a smoking cessation study using the nicotine transdermal patch. Richmond, RL., Kehoe, L., de Almeida Neto, AC.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Measuring the chemical and cytotoxic variability of commercially available kava (Piper methysticum G. Forster). [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

An Updated Review on the Psychoactive, Toxic and Anticancer Properties of Kava. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of kava extract in the treatment of anxiety. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Kava as a Clinical Nutrient: Promises and Challenges. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Complementary treatments for tobacco cessation: a survey. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation products and programs. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of studies investigating one-year effectiveness of transdermal nicotine patches for smoking cessation. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Alternative smoking cessation aids: a meta-analysis of randomized controlled trials. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Three year continuous abstinence in a smoking cessation study using the nicotine transdermal patch. [2019]