Kava for Smoking
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a daily kava regimen to evaluate compliance and its effects on tobacco use and dependence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Kava
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Florida Department of Health
Collaborator