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

NCT05758298 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-09-07

No results posted yet for this study

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

Interventions

OTHER

Non-medicated gum

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

DRUG

NICOTINE 2MG GUM

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

DRUG

NICOTINE 4MG GUM

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

Sponsors & Collaborators

  • Commonwealth Healthcare Corporation

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Mary Chang, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-12-31
Completion
2024-12-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758298 on ClinicalTrials.gov