Kava for Smoking

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Overseen ByRamzi Salloum, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Florida
Prior Safety DataThis treatment has passed at least one previous human trial

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, a plant-based supplement, is under study for its potential benefits and safety. Some studies have found that kava is generally safe when taken in controlled amounts, with most participants not experiencing serious side effects. However, some reported mild side effects, such as drowsiness or an upset stomach.

In rare cases, kava has been linked to liver problems, typically with high doses or long-term use. As this trial is in an early stage, researchers are still gathering information on kava's safety and effectiveness. Notably, kava is already used in some countries to help with anxiety, providing some insight into its safety.

Prospective trial participants should note that the research team will closely monitor health and any side effects experienced.

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?

Research suggests that kava, which participants in this trial may receive, might help reduce tobacco use and dependence. Previous studies have found that kava has calming effects, which could help smokers manage cravings and the anxiety associated with quitting. Some early results indicate that kava might lessen the urge to smoke, although more research is needed to confirm this. While the exact effect of kava on reducing lung cancer risk remains under study, its potential to aid smoking cessation could indirectly lower such risks. Overall, kava shows promise as a tool to support efforts to quit tobacco.

Who Is on the Research Team?

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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
See 5 more

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
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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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Kava InterventionExperimental 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+

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.
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.
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.
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]

Citations

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