NCT05758298

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Betel Nut Cessation

Interventions

Type	Name	Description
OTHER	Non-medicated gum	Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
DRUG	NICOTINE 2MG GUM	Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
DRUG	NICOTINE 4MG GUM	Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-03-07
• Last updated: 2023-09-07

Regulatory

• FDA-regulated drug study