drugset / Trial / NCT05758298

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

NCT05758298

RandomizedParallel-groupSingle-blindPrevention

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

Timeline

Start
2023-10-01
Primary completion
2024-12
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 2 mg
Subject Nicotine Unknown 4 mg

Indications

No indication recorded.