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(352) 733-0111

Holistic Effects Associated with Tobacco Abstinence

  • Status
    Accepting Candidates
  • Age
    21 Years - 99 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated with Abstinence
Protocol number OCR44061
ClinicalTrials.gov ID NCT05814055
Phase Phase 2

Eligibility

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 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.

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Ramzi Salloum
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.