What side effects are associated with this type of intervention?

Common treatments for smoking cessation include pharmacologic options like varenicline, bupropion, and nicotine replacement therapy (NRT). Varenicline can cause nausea, vivid dreams, and sleep disturbances. Bupropion may lead to insomnia, dry mouth, and in rare cases, seizures. NRT, available as patches, gums, or sprays, often causes local irritation, such as skin rash or mouth irritation. Behavioral interventions, including counseling and mindfulness, generally have minimal side effects but require significant patient commitment. Alternative treatments like kava are being studied for their potential to reduce tobacco use and lung carcinogenesis, but their side effect profile is not yet well-established.

What prior FDA approvals exist?

The FDA has approved several treatments for smoking cessation, including nicotine replacement therapy (NRT) products like patches, gums, and lozenges, which help reduce withdrawal symptoms and cravings. Bupropion, an antidepressant, and varenicline, a partial nicotine receptor agonist, are also approved and work by reducing cravings and withdrawal symptoms. These treatments aim to reduce tobacco use and dependence, similar to the goals of the kava study, which is investigating whether kava can reduce tobacco use and lung carcinogenesis. While kava's potential impact on lung cancer risk is a novel aspect, the primary focus on reducing tobacco dependence aligns with existing FDA-approved therapies.

What other types of research exist?

Promising novel alternatives to Kava for smoking patients include: 1) Low-nitrosamine smokeless tobacco (SLT) like Camel Snus, which has shown potential for smoking reduction and cessation. 2) Nicotine patch therapy combined with physician advice and nurse follow-up, which has demonstrated significant smoking cessation rates. 3) Swedish snus, which has been used successfully in Scandinavia for smoking cessation and is currently being evaluated in clinical trials.

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Other

Kava for Smoking

Phase 2

Recruiting

Led By Ramzi Salloum, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing whether kava, a safe and effective herbal remedy, can help people quit smoking cigarettes and reduce their risk of developing lung cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants should avoid hepatotoxic substances due to kava's potential impact on liver function; this suggests monitoring for liver-related side effects may be part of the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Subject Compliance with Intervention

Secondary outcome measures

Tobacco cessation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Kava InterventionExperimental Treatment1 Intervention

Group II: Placebo ControlPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Kava

2015

N/A

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for smoking cessation include pharmacologic options like nicotine replacement therapy (NRT), bupropion, and varenicline, which work by reducing withdrawal symptoms and cravings through different mechanisms in the brain. Behavioral treatments such as counseling and mindfulness help patients develop coping strategies and change their smoking behaviors. The trial on Kava suggests it may reduce tobacco use and dependence and lower lung cancer risk, which is crucial for smoking patients as it addresses both immediate addiction and long-term health consequences.

[Cigarette smoking. A pilot project of dehabituation and experimental research].Combination treatment for nicotine dependence: state of the science.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,351 Previous Clinical Trials

722,227 Total Patients Enrolled

2 Trials studying Smoking

120 Patients Enrolled for Smoking

Florida Department of HealthOTHER_GOV

28 Previous Clinical Trials

12,919 Total Patients Enrolled

Ramzi Salloum, PhDPrincipal InvestigatorUniversity of Florida

5 Previous Clinical Trials

3,112 Total Patients Enrolled

1 Trials studying Smoking

76 Patients Enrolled for Smoking

Media Library

Kava (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05081882 — Phase 2

Smoking Clinical Trial 2023: Kava Highlights & Side Effects. Trial Name: NCT05081882 — Phase 2

Kava (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081882 — Phase 2

Smoking Research Study Groups: Kava Intervention, Placebo Control

~11 spots leftby Nov 2024

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