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| ID | Type | Description | Link |
|---|---|---|---|
| OCR40933 | Other Identifier | University of Florida | |
| IRB202101885 | Other Identifier | University of Florida IRB-01 |
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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians.
This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kava Intervention | Experimental |
| |
| Placebo Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kava | Drug | Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days. |
|
| 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 | 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 | Affiliation | Role |
|---|---|---|
| Ramzi Salloum, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36653872 | Derived | Xing C, Malaty J, Malham MB, Nehme AMA, Freeman B, Huo Z, Firpi-Morrel R, Salloum RG. Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava. Trials. 2023 Jan 18;24(1):36. doi: 10.1186/s13063-023-07081-x. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Participants on this arm will take one placebo capsule orally three times daily for 28 days. |
|
| 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 |
| D015438 |
| Health Behavior |