RECRUITING

The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence

Conditions

Smoking kava smoking cessation tobacco dependence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.

Official Title

The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence

Quick Facts

Study Start:2024-06-06

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05814055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* adults aged 21 years or above (legal age for smoking in the U.S.); * self-reported smoking at least 10 cigarette/day for the past year with INTENTION to quit; * expired carbon monoxide level of more than 8 ppm at recruitment; * willingness to participate in the proposed study; * access to a functional telephone; * expected presence in the study's geographical area for the next 4 months; * not currently enrolled in any smoking cessation programs; and * female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, IUD, Diaphragm, and cervical cap).	* diagnosed with cancer (other than non-melanoma skin cancer); * diagnosed with liver dysfunction or with previous liver diseases; * levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen; * inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances; * use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or * are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study; * participant answered "Yes" to any of the Modified Ask Suicide Screening Questions questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place \>12 months from screening visit then subject is still eligible.

Inclusion Criteria

Exclusion Criteria

* adults aged 21 years or above (legal age for smoking in the U.S.);
* self-reported smoking at least 10 cigarette/day for the past year with INTENTION to quit;
* expired carbon monoxide level of more than 8 ppm at recruitment;
* willingness to participate in the proposed study;
* access to a functional telephone;
* expected presence in the study's geographical area for the next 4 months;
* not currently enrolled in any smoking cessation programs; and
* female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, IUD, Diaphragm, and cervical cap).

* diagnosed with cancer (other than non-melanoma skin cancer);
* diagnosed with liver dysfunction or with previous liver diseases;
* levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
* inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
* use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or
* are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
* participant answered "Yes" to any of the Modified Ask Suicide Screening Questions questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place \>12 months from screening visit then subject is still eligible.

Contacts and Locations

Principal Investigator

Ramzi Salloum, PhD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32608

United States

Collaborators and Investigators

Sponsor: University of Florida

Ramzi Salloum, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-06

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-06-06

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

kava
smoking cessation
tobacco dependence

Additional Relevant MeSH Terms

Smoking