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

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Drug: AB-free kava
* Drug: Placebo
* Drug: AB-free kava


Participation Criteria
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Eligibility Criteria
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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 ASQ questions 1 through 4, or refuses to answer.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full dose kava intervention<br> | Drug: AB-free kava<br>* Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.<br>|
| Experimental: Half dose kava intervention<br> | Drug: AB-free kava<br>* Participants on this arm will take one kava capsule (each capsule contains 37.5 mg of kavalactones) orally three times daily for 4 weeks.<br>|
| Placebo Comparator: Placebo control<br> | Drug: Placebo<br>* Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Compliance with Intervention | Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses | 4 weeks | 
| Subject Compliance with Intervention | Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND) | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ) | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief) | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents | 12 weeks | 
| Effect on stress | 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. | 12 weeks | 
| Effect on stress | Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA | 12 weeks | 
| Effect on stress | Examine whether kava has the potential to reduce stress, as measured by plasma cortisol | 12 weeks | 
| Effect on stress | Examine whether kava has the potential to reduce stress, as measured by urinary TCE | 12 weeks | 
| Effect on stress | Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents | 12 weeks | 
| Effect on sleep | 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. | 12 weeks | 
| Effect on sleep | Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI) | 12 weeks | 
| Effect on sleep | Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin | 12 weeks | 
| Effect on sleep | Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin | 12 weeks | 
| Effect on sleep | Examine whether kava has the potential to improve sleep, as measured by urinary NAS | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kava, smoking cessation, tobacco dependence