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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Commonwealth Healthcare Corporation
• Treatments: Nicotine

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 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