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

Early Phase 1

Withdrawn

• Conditions: Betel Nut Cessation
• Interventions: Other: Non-medicated gum; Drug: NICOTINE 2MG GUM; Drug: NICOTINE 4MG GUM

• Registration Number: NCT05758298
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07
• Study Start: 2023-10-01
• Primary Completion: 2024-12
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-medicated gum Arm	Non-medicated gum	Participants in this group will receive the non-medicated gum in mint flavor.
Nicotine 2mg gum Arm	NICOTINE 2MG GUM	Participants in this group will receive the 2mg Nicotine gum in mint flavor.
Nicotine 4mg gum Arm	NICOTINE 4MG GUM	Participants in this group will receive the 4mg Nicotine gum in mint flavor.

Primary Outcome Measures

Name	Time	Method
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