The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Full dose kava intervention
|
Drug: AB-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.
|
| Experimental: Half dose kava intervention
|
Drug: AB-free kava
Participants on this arm will take one kava capsule (each capsule contains 37.5 mg of kavalactones) orally three times daily for 4 weeks.
|
| Placebo Comparator: Placebo control
|
Drug: Placebo
Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Subject Compliance with Intervention [4 weeks]
Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
- Subject Compliance with Intervention [4 weeks]
Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine
Secondary Outcome Measures
- Tobacco cessation [12 weeks]
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked
- Tobacco cessation [12 weeks]
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)
- Tobacco cessation [12 weeks]
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)
- Tobacco cessation [12 weeks]
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)
- Tobacco cessation [12 weeks]
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents
- Effect on stress [12 weeks]
Examine whether kava has the potential to reduce stress, as measured by the Perceived Stress Scale (PSS)
- Effect on stress [12 weeks]
Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA
- Effect on stress [12 weeks]
Examine whether kava has the potential to reduce stress, as measured by plasma cortisol
- Effect on stress [12 weeks]
Examine whether kava has the potential to reduce stress, as measured by urinary TCE
- Effect on stress [12 weeks]
Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents
- Effect on sleep [12 weeks]
Examine whether kava has the potential to improve sleep, as measured by the Insomnia Severity Scale
- Effect on sleep [12 weeks]
Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)
- Effect on sleep [12 weeks]
Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin
- Effect on sleep [12 weeks]
Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin
- Effect on sleep [12 weeks]
Examine whether kava has the potential to improve sleep, as measured by urinary NAS
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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willingness to participate in the proposed study;
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access to a functional telephone;
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expected presence in the study's geographical area for the next 4 months;
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not currently enrolled in any smoking cessation programs; and
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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:
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diagnosed with cancer (other than non-melanoma skin cancer);
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diagnosed with liver dysfunction or with previous liver diseases;
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levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
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inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
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use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or
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are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
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participant answered "Yes" to any of the ASQ questions 1 through 4, or refuses to answer.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Florida
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Ramzi Salloum, PhD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Kava 2