Kava for Smoking

Overseen By Ramzi Salloum, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Disqualifiers: Active 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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a kava regimen to help smokers in Florida who do not want to quit. Kava is a plant that may help reduce the urge to smoke and lower lung cancer risk. The study aims to see if kava can make it easier for people to cut down on smoking and improve their health.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must refrain from using acetaminophen, alcohol (more than one drink daily), or other potentially hepatotoxic substances.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to refrain from using acetaminophen and limit alcohol to no more than one drink daily.

What data supports the idea that Kava for Smoking is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Kava for Smoking. Instead, it focuses on the placebo effects of nicotine and other smoking cessation methods, like nicotine gum and patches. These studies highlight the role of belief in the effectiveness of treatments, but they do not directly address Kava's impact on smoking cessation. Therefore, there is no direct evidence from the provided information that Kava is an effective treatment for smoking. ^{1 2 3 4 5}

What safety data is available for kava as a treatment?

Kava extracts are generally well-tolerated when used short-term at recommended doses, with most adverse events being mild and reversible. However, serious adverse events, including liver damage, have been reported. Variability in chemical composition and cytotoxicity of kava products exists, and quality control is essential to prevent hepatotoxicity. Further research is needed to better understand the nature and frequency of serious adverse events. A six-point plan for kava standardization has been proposed to improve safety. ^{6 7 8 9 10}

Is kava safe for human use?

Kava is generally considered safe for short-term use at recommended doses, but there have been reports of serious side effects, including liver damage and skin reactions. It's important to ensure the kava product is of high quality and to be cautious of potential interactions with other medications. ^{6 7 8 9 10}

Is Kava a promising treatment for smoking?

Yes, Kava shows promise as a treatment for smoking. It may help reduce cravings and the harmful effects of smoking, like lung cancer risk, by detoxifying harmful substances and lowering stress levels. ^{7 10 11 12 13}

How does the drug Kava differ from other treatments for smoking cessation?

Kava is unique because it may reduce cravings associated with addiction by interacting with brain sites linked to craving, and it potentially reduces lung cancer risk by enhancing detoxification of harmful tobacco compounds. Unlike other treatments, kava also has calming effects and may lower stress, which can help with smoking cessation. ^{7 10 11 12 13}

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 and have no plans to quit. They must live in the study area for the next 4 months, not be in cessation programs, and use birth control if applicable. It's not for those with liver issues, cancer (except skin), pregnant/nursing women, or users of other nicotine products.

Inclusion Criteria

Adults aged 21 years or above

Willingness to participate in the proposed study

Access to a functional telephone

Exclusion Criteria

Diagnosed with liver dysfunction or with previous liver diseases

Diagnosed with cancer (other than non-melanoma skin cancer)

Are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study

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 use and dependence

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Kava
• Placebo

Trial Overview The trial tests whether kava can help active smokers reduce tobacco use without intending to quit smoking. Participants will take kava daily while their compliance, reduction in smoking habits, and potential decrease in lung cancer risk are monitored.

Participant Groups

Group I: Kava Intervention 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+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Findings from Research

In a study of 411 smokers over 24 months, nicotine gum significantly increased the rate of smoking reduction and cessation compared to placebo, with success rates of 6.3% versus 0.5% for reduction and 11.2% versus 3.9% for cessation at 12 months.

The study found a correlation between reduced daily cigarette consumption and lower levels of nicotine and toxins in the body, although some smokers compensated by smoking more when using nicotine gum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up. Wennike, P., Danielsson, T., Landfeldt, B., et al.[2022]

A clinical trial involving 216 participants aims to compare the effectiveness of pre-quit treatments (nicotine patch and varenicline) against standard post-quit patch treatment to improve smoking cessation success rates.

By monitoring participants' smoking behaviors and withdrawal symptoms in real-time, the study seeks to understand how these treatments work, which could lead to more personalized and effective smoking cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of the mechanism of action of two pre-quit pharmacotherapies for smoking cessation. Ferguson, SG., Walters, JA., Lu, W., et al.[2018]

Laboratory studies suggest that the expectation of nicotine can significantly reduce smoking cravings and withdrawal symptoms, indicating a strong placebo effect associated with nicotine use.

Field trials of nicotine replacement therapy often fail to account for smokers' beliefs about their treatment, making it challenging to determine whether observed benefits are due to the actual pharmacological effects of nicotine or the placebo effect from expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of beliefs regarding drug assignment in experimental and field studies of nicotine delivery devices: a review. Dar, R., Barrett, SP.[2018]

Nicotine is important for smoking behavior, but nonpharmacological factors, including placebo effects, also significantly influence whether people continue to smoke.

Understanding the placebo effects related to smoking and nicotine intake could enhance the effectiveness of nicotine replacement therapies and inform better treatment strategies for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo effects of tobacco smoking and other nicotine intake. Perkins, K., Sayette, M., Conklin, C., et al.[2015]

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]

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]

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 a history of safe use, but recent cases of liver injury linked to poor quality raw materials highlight the need for strict quality standards in kava production, especially for traditional and dietary supplements.

To ensure the safety and efficacy of kava as an anxiolytic, a six-point solution plan is proposed, emphasizing the use of noble cultivars, proper harvesting and processing methods, and rigorous quality control measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kava hepatotoxicity solution: A six-point plan for new kava standardization. Teschke, R., Sarris, J., Lebot, V.[2016]

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]

Preliminary studies suggest that kava, particularly its active ingredients called kavapyrones, may help reduce cravings for substances like alcohol, tobacco, cocaine, and heroin, indicating potential as a treatment for addiction.

In one pilot study, participants who received a standardized amount of kavapyrones reported a significant reduction in their desire for their drug of choice, and there was a notable difference in abstinence rates between those taking kava and a placebo for alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kava as an anticraving agent: preliminary data. Steiner, GG.[2022]

Kava, a traditional beverage from the South Pacific, has been shown to suppress the activation of NF-kappaB in lung adenoma tissues, which may contribute to its potential as a chemopreventive agent against cancer.

Methysticin, a compound found in kava, is identified as a strong inhibitor of NF-kappaB with minimal toxicity, suggesting it could be a safe option for cancer prevention compared to other kava constituents that have less inhibitory activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of methysticin as a potent and non-toxic NF-kappaB inhibitor from kava, potentially responsible for kava's chemopreventive activity. Shaik, AA., Hermanson, DL., Xing, C.[2022]

A pilot clinical trial showed that a 7-day course of kava increased the excretion of NNK metabolites in active smokers, indicating enhanced detoxification of the carcinogenic compound NNK, which is linked to lung cancer.

Kava also reduced nicotine levels and cortisol in participants, suggesting it may help with tobacco cessation and potentially lower lung cancer risk among smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of One-week Dietary Supplementation with Kava on Biomarkers of Tobacco Use and Nitrosamine-based Carcinogenesis Risk among Active Smokers. Wang, Y., Narayanapillai, SC., Tessier, KM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Examination of the mechanism of action of two pre-quit pharmacotherapies for smoking cessation. [2018]

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

The effects of beliefs regarding drug assignment in experimental and field studies of nicotine delivery devices: a review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Placebo effects of tobacco smoking and other nicotine intake. [2015]

5. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

8. 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]

9. Germany pubmed.ncbi.nlm.nih.gov

Kava hepatotoxicity solution: A six-point plan for new kava standardization. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Kava as an anticraving agent: preliminary data. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Identification of methysticin as a potent and non-toxic NF-kappaB inhibitor from kava, potentially responsible for kava's chemopreventive activity. [2022]

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

The Impact of One-week Dietary Supplementation with Kava on Biomarkers of Tobacco Use and Nitrosamine-based Carcinogenesis Risk among Active Smokers. [2021]