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

NCT ID: NCT05758298

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-12-01

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.

Conditions

Betel Nut Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Non-medicated gum Arm

Participants in this group will receive the non-medicated gum in mint flavor.

Group Type: PLACEBO_COMPARATOR

Non-medicated gum

Intervention Type: OTHER

Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Nicotine 2mg gum Arm

Participants in this group will receive the 2mg Nicotine gum in mint flavor.

Group Type: EXPERIMENTAL

NICOTINE 2MG GUM

Intervention Type: DRUG

Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Nicotine 4mg gum Arm

Participants in this group will receive the 4mg Nicotine gum in mint flavor.

Group Type: EXPERIMENTAL

NICOTINE 4MG GUM

Intervention Type: DRUG

Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Interventions

Non-medicated gum

Non-medicated, regular chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Intervention Type: OTHER

NICOTINE 2MG GUM

Nicotine 2mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Intervention Type: DRUG

NICOTINE 4MG GUM

Nicotine 4mg chewing gum in mint flavor (6 pieces of gum per day given, but used as needed).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Commonwealth Healthcare Corporation

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mary Chang

ASSOC PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Chang, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Other Identifiers

STU-2022-1040

Identifier Type: -

Identifier Source: org_study_id