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

NCT05758298 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: STU-2022-1040
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Betel Nut Cessation

Keywords

replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Non-medicated gum Arm

PLACEBO COMPARATOR

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

Other: Non-medicated gum

Nicotine 2mg gum Arm

EXPERIMENTAL

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

Drug: NICOTINE 2MG GUM

Nicotine 4mg gum Arm

EXPERIMENTAL

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

Drug: NICOTINE 4MG GUM

Interventions

Non-medicated gum OTHER

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

Non-medicated gum Arm

NICOTINE 2MG GUM DRUG

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

Nicotine 2mg gum Arm

NICOTINE 4MG GUM DRUG

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

Nicotine 4mg gum Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Commonwealth Healthcare Corporation: collaborator

MeSH Terms

Interventions

Nicotine; Chewing Gum

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mary Chang, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Consenting research team members will not know the order of the randomization schedule or what numbers correspond to treatment options. Blinded members of the research team will receive the participants chew logs for analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share