The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence
NCT ID: NCT05814055
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
76 participants
INTERVENTIONAL
2024-06-06
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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AB-free kava
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.
Placebo control
Placebo
Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
Interventions
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Placebo
Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
21 Years
75 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institutes of Health (NIH)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Ramzi Salloum, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Xing C, Malaty J, Malham MB, Orlando FA, Lynch A, Huo Z, Francois M, Firpi-Morell R, Fisher CL, Christou DD, Salloum RG. The potential of AB-free kava in enabling tobacco cessation via management of abstinence-related stress and insomnia: study protocol for a randomized clinical trial. BMC Complement Med Ther. 2024 Dec 21;24(1):422. doi: 10.1186/s12906-024-04722-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Kava 2
Identifier Type: -
Identifier Source: org_study_id
OCR44061
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202300887
Identifier Type: OTHER
Identifier Source: secondary_id
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