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

The University of Texas System (UT)

Status and phase: Withdrawn; Early Phase 1

Conditions: Betel Nut Cessation

Treatments: Drug: NICOTINE 2MG GUM; Other: Non-medicated gum; Drug: NICOTINE 4MG GUM

Study type: Interventional

Funder types: Other

Identifiers

NCT05758298

STU-2022-1040

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Non-medicated gum Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Non-medicated gum

Nicotine 2mg gum Arm

Experimental group

Description:

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

Treatment:

Drug: NICOTINE 2MG GUM

Nicotine 4mg gum Arm

Experimental group

Description:

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

Treatment:

Drug: NICOTINE 4MG GUM