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| ID | Type | Description | Link |
|---|---|---|---|
| OCR44061 | Other Identifier | University of Florida | |
| IRB202300887 | Other Identifier | University of Florida | |
| 1R33AT012328-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB-free kava | Experimental |
| |
| Placebo control | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants on this arm will take one placebo capsule orally three times daily for 4 weeks. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramzi G Dr. Salloum | Contact | 352-294-4997 | rsalloum@ufl.edu | |
| Chengguo Dr. Xing | Contact | 352-294-8511 | chengguoxing@cop.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ramzi Salloum, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39709468 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2024 | Jan 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| AB-free kava | Drug | Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks. |
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| 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 |
| D001523 |
| Mental Disorders |