Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan

Study Overview
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Brief Summary
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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: non-medicated regular chewing gum nicotine 2 mg gum nicotine 4 mg gum

Detailed Description
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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.

Official Title
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Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan

Conditions
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Betel Nut Cessation

Intervention / Treatment
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* Other: Non-medicated gum
* Drug: NICOTINE 2MG GUM
* Drug: NICOTINE 4MG GUM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily betel nut chewers who use betel nut and tobacco in their chews. Interested in betel nut reduction or cessation when they are informed of the study. Must chew greater than or equal to 4 times a day. Must have an appointment with a provider at the Commonwealth Healthcare Corporation Exclusion Criteria: Tobacco smokers Under the age of 18 years old Potential subjects unable to accurately estimate the number of average betel nut chews per day (will be able to re-present for enrollment if they are able to make an accurate estimate of chews per day after keeping a personal record chew for one week or more) Pregnant patients Established diagnosis of oropharyngeal cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-medicated gum Arm<br>Participants in this group will receive the non-medicated gum in mint flavor. | Other: Non-medicated gum<br>* Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).<br>|
| Experimental: Nicotine 2mg gum Arm<br>Participants in this group will receive the 2mg Nicotine gum in mint flavor. | Drug: NICOTINE 2MG GUM<br>* Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).<br>|
| Experimental: Nicotine 4mg gum Arm<br>Participants in this group will receive the 4mg Nicotine gum in mint flavor. | Drug: NICOTINE 4MG GUM<br>* Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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replacement therapy