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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05758298

Collaborator

Commonwealth Healthcare Corporation (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Betel Nut Cessation	Other: Non-medicated gum Drug: NICOTINE 2MG GUM Drug: NICOTINE 4MG GUM	Early Phase 1

Detailed Description

Objectives include:

Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.
Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.
Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Texas Southwestern Medical Center
Commonwealth Healthcare Corporation

Investigators

Principal Investigator: Mary Chang, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary Chang, ASSOC PROFESSOR, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT05758298

Other Study ID Numbers:

STU-2022-1040

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mary Chang, ASSOC PROFESSOR, University of Texas Southwestern Medical Center

replacement therapy

Additional relevant MeSH terms:

Nicotine

Study Results

No Results Posted as of Mar 7, 2023