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

Primary Purpose

Smoking

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AB-free kava
Placebo
AB-free kava
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring kava, smoking cessation, tobacco dependence

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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). Exclusion Criteria: 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 ASQ questions 1 through 4, or refuses to answer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Full dose kava intervention

    Half dose kava intervention

    Placebo control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Subject Compliance with Intervention
    Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
    Subject Compliance with Intervention
    Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing

    Secondary Outcome Measures

    Tobacco cessation
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked
    Tobacco cessation
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)
    Tobacco cessation
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)
    Tobacco cessation
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)
    Tobacco cessation
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents
    Effect on stress
    Examine whether kava has the potential to reduce stress, as measured by the Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 40 and the minimum score is 0. A higher score indicates greater perceived stress.
    Effect on stress
    Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA
    Effect on stress
    Examine whether kava has the potential to reduce stress, as measured by plasma cortisol
    Effect on stress
    Examine whether kava has the potential to reduce stress, as measured by urinary TCE
    Effect on stress
    Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents
    Effect on sleep
    Examine whether kava has the potential to improve sleep, as measured by the Insomnia Severity Scale. The Insomnia Severity Scale instrument consists of 7 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 28 and the minimum score is 0. A higher score indicates more severe insomnia.
    Effect on sleep
    Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)
    Effect on sleep
    Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin
    Effect on sleep
    Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin
    Effect on sleep
    Examine whether kava has the potential to improve sleep, as measured by urinary NAS

    Full Information

    First Posted
    April 3, 2023
    Last Updated
    September 28, 2023
    Sponsor
    University of Florida
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05814055
    Brief Title
    The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
    Official Title
    The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking
    Keywords
    kava, smoking cessation, tobacco dependence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Full dose kava intervention
    Arm Type
    Experimental
    Arm Title
    Half dose kava intervention
    Arm Type
    Experimental
    Arm Title
    Placebo control
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    AB-free kava
    Intervention Description
    Participants on this arm will take one kava capsule (each capsule contains 37.5 mg of kavalactones) orally three times daily for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    AB-free kava
    Intervention Description
    Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.
    Primary Outcome Measure Information:
    Title
    Subject Compliance with Intervention
    Description
    Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
    Time Frame
    4 weeks
    Title
    Subject Compliance with Intervention
    Description
    Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Tobacco cessation
    Description
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked
    Time Frame
    12 weeks
    Title
    Tobacco cessation
    Description
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)
    Time Frame
    12 weeks
    Title
    Tobacco cessation
    Description
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)
    Time Frame
    12 weeks
    Title
    Tobacco cessation
    Description
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)
    Time Frame
    12 weeks
    Title
    Tobacco cessation
    Description
    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents
    Time Frame
    12 weeks
    Title
    Effect on stress
    Description
    Examine whether kava has the potential to reduce stress, as measured by the Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 40 and the minimum score is 0. A higher score indicates greater perceived stress.
    Time Frame
    12 weeks
    Title
    Effect on stress
    Description
    Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA
    Time Frame
    12 weeks
    Title
    Effect on stress
    Description
    Examine whether kava has the potential to reduce stress, as measured by plasma cortisol
    Time Frame
    12 weeks
    Title
    Effect on stress
    Description
    Examine whether kava has the potential to reduce stress, as measured by urinary TCE
    Time Frame
    12 weeks
    Title
    Effect on stress
    Description
    Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents
    Time Frame
    12 weeks
    Title
    Effect on sleep
    Description
    Examine whether kava has the potential to improve sleep, as measured by the Insomnia Severity Scale. The Insomnia Severity Scale instrument consists of 7 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 28 and the minimum score is 0. A higher score indicates more severe insomnia.
    Time Frame
    12 weeks
    Title
    Effect on sleep
    Description
    Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)
    Time Frame
    12 weeks
    Title
    Effect on sleep
    Description
    Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin
    Time Frame
    12 weeks
    Title
    Effect on sleep
    Description
    Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin
    Time Frame
    12 weeks
    Title
    Effect on sleep
    Description
    Examine whether kava has the potential to improve sleep, as measured by urinary NAS
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion 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). Exclusion Criteria: 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 ASQ questions 1 through 4, or refuses to answer.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ramzi Salloum, PhD
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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