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Have not received IRB approval.
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| Name | Class |
|---|---|
| Commonwealth Healthcare Corporation | OTHER |
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The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their chew. One of the study team members will be traveling to Commonwealth of Northern Mariana Islands and a letter of support has been obtained in order to conduct the study.
Eligible patients must be non-tobacco smokers, be actively interested in betel nut reduction or cessation, and chew at least four times a day on average. Subjects will be randomized equally into three distinct groups for the purpose of this study:
Objectives include:
A. Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.
B. Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.
C. Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-medicated gum Arm | Placebo Comparator | Participants in this group will receive the non-medicated gum in mint flavor. |
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| Nicotine 2mg gum Arm | Experimental | Participants in this group will receive the 2mg Nicotine gum in mint flavor. |
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| Nicotine 4mg gum Arm | Experimental | Participants in this group will receive the 4mg Nicotine gum in mint flavor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-medicated gum | Other | Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in average "betel nut chews per day" at 3 months | Average "betel nut chews per day" will be calculated by taking average of one full week of self-reported daily chews | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Chang, MD | University of Texas Southwestern Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Consenting research team members will not know the order of the randomization schedule or what numbers correspond to treatment options. Blinded members of the research team will receive the participants chew logs for analysis
| NICOTINE 2MG GUM | Drug | Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed). |
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| NICOTINE 4MG GUM | Drug | Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed). |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |