Clinical trial NCT05814055: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Smoking
Keywords: kava
smoking cessation
tobacco dependence
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institutes of Health (NIH)
First posted: 2023-04-14
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* adults aged 21 years or above (legal age for smoking in the U.S.) up to 99 years old;
* 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).
* if a participant takes kava dietary supplement, a 2-week washout period is needed for the participant to initiate this study or if a participant participated in a kava trial before, such as the kava JEK trial, the participant could be enrolled if the inclusion criteria above are met, including the 2-week washout period.

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.

Primary outcomes:
measure: Subject Compliance with Intervention
timeFrame: 4 weeks
measure: Subject Compliance with Intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Effect on stress
timeFrame: 12 weeks
measure: Effect on stress
timeFrame: 12 weeks
measure: Effect on stress
timeFrame: 12 weeks
measure: Effect on stress
timeFrame: 12 weeks
measure: Effect on stress
timeFrame: 12 weeks
measure: Effect on sleep
timeFrame: 12 weeks
measure: Effect on sleep
timeFrame: 12 weeks
measure: Effect on sleep
timeFrame: 12 weeks
measure: Effect on sleep
timeFrame: 12 weeks
measure: Effect on sleep
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ramzi Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References: