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

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

Study Overview

• Status: Withdrawn
• Conditions: Betel Nut Cessation
• Intervention / Treatment: Other: Non-medicated gum; Drug: NICOTINE 2MG GUM; Drug: NICOTINE 4MG 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 Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Non-medicated gum Arm; Participants in this group will receive the non-medicated gum in mint flavor.	Other: Non-medicated gum; Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
Experimental: Nicotine 2mg gum Arm; Participants in this group will receive the 2mg Nicotine gum in mint flavor.	Drug: NICOTINE 2MG GUM; Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).
Experimental: Nicotine 4mg gum Arm; Participants in this group will receive the 4mg Nicotine gum in mint flavor.	Drug: NICOTINE 4MG GUM; Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average "betel nut chews per day" at 3 months	Average "betel nut chews per day" will be calculated by taking average of one full week of self-reported daily chews	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Commonwealth Healthcare Corporation
• Investigators: Principal Investigator: Mary Chang, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: replacement therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: STU-2022-1040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No