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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a daily kava regimen can help smokers reduce tobacco use and lower lung cancer risk. Researchers aim to determine if kava, a plant-based supplement, can offer a new method for those who smoke and do not plan to quit. Participants will receive either kava or a placebo to compare effects. Ideal candidates are adults who smoke at least five cigarettes a day and do not intend to quit soon. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, giving participants a chance to contribute to potentially groundbreaking findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that kava has traditionally helped people feel calm. Recent studies have explored its safety for treating various conditions, indicating that most people tolerate kava well. Some users report minor side effects like headaches or stomach upset, but these are uncommon.

Evidence also suggests that kava does not cause serious harm when used in recommended amounts. However, high doses or prolonged use have been linked to liver problems in the past, prompting some countries to regulate its sale and use.

Since this trial is in the early stages of clinical research, the focus is on how kava affects people who smoke. Previous research has shown it to be somewhat safe, but ongoing studies will provide more information. Always consult healthcare providers to understand potential risks and benefits before joining a trial.

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for smoking cessation, which often involve nicotine replacement therapies or medications like varenicline and bupropion, kava is derived from the roots of the kava plant and is known for its calming effects. Researchers are excited about kava because it offers a natural alternative that may help reduce cravings and manage withdrawal symptoms without the use of nicotine or synthetic drugs. Additionally, kava's unique mechanism of action as an anxiolytic could address the stress and anxiety often associated with quitting smoking, potentially improving success rates for those trying to quit.

What evidence suggests that kava might be an effective treatment for smoking cessation?

This trial will compare the effects of Kava with a placebo in helping individuals reduce smoking. Research has shown that Kava, a plant from the South Pacific, might help reduce anxiety and stress, which often lead to smoking. Early findings suggest it could help people smoke less by calming cravings and easing withdrawal symptoms. Some studies found that Kava can lift mood and lessen the urge to smoke. Although data on its direct impact on quitting smoking is limited, its calming effects seem promising for helping people cut back. More research is needed to confirm its effectiveness specifically for quitting smoking and reducing lung cancer risk.

Who Is on the Research Team?

Ramzi Salloum, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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]

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]

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, 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 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]

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]

Citations