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NCT05758298
Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan
Conditions: Betel Nut Cessation
Sex: All
Ages: 18 Years – 99 Years
Phase: EARLY_PHASE1
Enrollment: 45
Sponsor: University of Texas Southwestern Medical Center
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 gumnicotine 2 mg gumnicotine 4 mg gum
Eligibility Criteria
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 CorporationExclusion Criteria:Tobacco smokersUnder the age of 18 years oldPotential 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 patientsEstablished diagnosis of oropharyngeal cancer
Source: ClinicalTrials.gov (NCT05758298). StuddyBuddy aggregates publicly available trial information.