University of Hawai'i
Honolulu, Hawaii, 96813, United States
NCT Number: NCT07075575
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Honolulu, Hawaii, 96813, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 weeks after baseline (Study Visit 8)
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: Baseline to 12 weeks
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 participants' confidence in their ability to quit smoking, measured using a validated smoking self-efficacy scale.
Time frame: Throughout the 12-week intervention period
Frequency and severity of adverse events related to nicotine gum or study procedures, as reported by participants or observed by study staff.
Contact information is provided by the study sponsor or research team.
Pallav Pokhrel, PhD, MPH
CONTACT
Yoko Takahashi, MD
CONTACT
University of Hawaii
Other
Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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