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

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

A) adults aged 21 years or above (legal age for smoking in the U.S.);

B) self-reported smoking at least 10 cigarette/day for the past year with INTENTION to quit;

C) expired carbon monoxide level of more than 8 ppm at recruitment;

D) willingness to participate in the proposed study;

E) access to a functional telephone;

F) expected presence in the study's geographical area for the next 4 months;

G) not currently enrolled in any smoking cessation programs; and

H) 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:

A) diagnosed with cancer (other than non-melanoma skin cancer);

B) diagnosed with liver dysfunction or with previous liver diseases;

C) levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;

D) inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;

E) use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or

F) are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;

G) participant answered "Yes" to any of the ASQ questions 1 through 4, or refuses to answer.