Betel Nut Cessation
Conditions
Keywords
replacement therapy
Brief summary
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
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.
Interventions
OTHERNon-medicated gum
Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
DRUGNICOTINE 2MG GUM
Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
DRUGNICOTINE 4MG GUM
Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
Sponsors
Commonwealth Healthcare Corporation
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in average betel nut chews per day at 3 months | Baseline, 3 months | Average betel nut chews per day will be calculated by taking average of one full week of self-reported daily chews |
Outcome results
None listed