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RecruitingPhase 2NCT05814055

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

Sponsor

University of Florida

Enrollment

76 participants

Start Date

Jun 6, 2024

Study Type

INTERVENTIONAL

Conditions

Smoking

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.

Eligibility

Min Age: 21 YearsMax Age: 75 Years

Inclusion Criteria8

  • adults aged 21 years or above (legal age for smoking in the U.S.) up to 75 years old;
  • self-reported smoking at least 5 cigarettes/day for the past year with INTENTION to quit at time of screening visit;
  • expired carbon monoxide level of more than 8 ppm at recruitment;
  • willingness to participate in the proposed study, as indicated by signed informed consent;
  • 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 per self report; 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 Criteria6

  • history of active cancer (other than non-melanoma skin cancer) within the past 2 years;
  • 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;
  • 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 3, or refuses to answer all of the questions. 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.

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Interventions

DRUGPlacebo

Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.

DRUGAB-free kava

Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.

Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05814055

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