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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 belowSelect...
You smoke at least 10 cigarettes per day and have no plans to quit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot use any other products that contain nicotine, like chewing tobacco, cigars, or e-cigarettes.You smoke at least 10 cigarettes per day and have no plans to quit.You cannot take acetaminophen, drink more than one alcoholic beverage per day, or use other substances that might harm your liver.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Kava Intervention
- Group 2: Placebo Control
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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