Smoking
Conditions
Keywords
kava, smoking cessation, tobacco dependence
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.
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.
Sponsors
University of Florida
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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). * 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Compliance with Intervention | 4 weeks | Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco cessation | 12 weeks | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked |
| Effect on stress | 12 weeks | 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 sleep | 12 weeks | 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. |
Countries
United States
Contacts
CONTACTRamzi G Dr. Salloum
CONTACTChengguo Dr. Xing
PRINCIPAL_INVESTIGATORRamzi Salloum, PhD
University of Florida
Outcome results
None listed