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Quit-Smoking Study for Native Hawaiians

NCT07075575 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-31

No results posted yet for this study

Summary

This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.

Conditions

  • Tobacco Use Disorder
  • Smoking Cessation

Interventions

DRUG

Nicotine Polacrilex Gum (2 mg)

Participants chew 2 mg nicotine gum according to a tapering 12-week schedule: Weeks 1-6: 1 piece every 1-2 hours; at least 9 pieces/day; Weeks 7-9: 1 piece every 2-4 hours; Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces/day. Gum is distributed every 2 weeks during study visits. Arm(s) Used In: NRT Gum Only CBGT + NRT Gum

BEHAVIORAL

Cognitive Behavioral Group Therapy (CBGT)

Participants attend six sessions of group-based cognitive behavioral therapy focused on smoking cessation, over the 12-week study period. Sessions include education on cravings, relapse prevention, stress management, and self-efficacy building. Arm(s) Used In: CBGT Only CBGT + NRT Gum

Sponsors & Collaborators

  • University of Hawaii

    lead OTHER

Principal Investigators

  • Crissy T Kawamoto · University of Hawai'i Cancer Center

  • Pallav Pokhrel, PhD, MPH · University of Hawai'i Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-11-01
Completion
2028-04-01

Countries

  • United States

Study Locations

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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 NCT07075575 on ClinicalTrials.gov