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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
Self-reported smoking at least 10 cigarette/day for the past year with no intention to quit
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You smoke at least 10 cigarettes per day and have no plans to quit.

Timeline

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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,625 Total Patients Enrolled
2 Trials studying Smoking
119 Patients Enrolled for Smoking
Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,923 Total Patients Enrolled
Ramzi Salloum, PhDPrincipal InvestigatorUniversity of Florida
5 Previous Clinical Trials
3,111 Total Patients Enrolled
1 Trials studying Smoking
75 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava
2022. "Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081882.
All > Smoking Cessation
~17 spots leftby Nov 2024
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