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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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
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
University of Hawai'i
Honolulu, Hawaii, United States
7-day point prevalence abstinence (PPA)
Self-reported 7-day point prevalence abstinence from cigarette smoking, confirmed by exhaled carbon monoxide (eCO) \<10 ppm at final follow-up visit.
Time frame: 12 weeks after baseline (Study Visit 8)
Change in nicotine dependence
Change in nicotine dependence scores as measured by standardized tools (e.g., Fagerström Test for Nicotine Dependence).
Time frame: Baseline to 12 weeks
Change in smoking self-efficacy
Change in participants' confidence in their ability to quit smoking, measured using a validated smoking self-efficacy scale.
Time frame: Baseline to 12 weeks
Number of adverse events
Frequency and severity of adverse events related to nicotine gum or study procedures, as reported by participants or observed by study staff.
Time frame: Throughout the 12-week intervention period
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