Quit-Smoking Study for Native Hawaiians
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Hawaii
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-identifies as full or part Native Hawaiian
Between the ages of 18 and 80 years, inclusive, at eligibility screening
Currently smoking ≥5 cigarettes per day (self-report) at eligibility screening
Has smoked more than 100 cigarettes in his/her lifetime (self-report)
Disqualifiers
Pregnant or nursing, or planning to become pregnant or breastfeed in the next three (3) months
Use of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking in the 30 days prior to eligibility screening
Use of other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) in the 30 days prior to eligibility screening
Use of smoked or vaped cannabis (i.e., marijuana) in the 30 days prior to eligibility screening
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotine Polacrilex Gum (2 mg)
DrugParticipants 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
Cognitive Behavioral Group Therapy (CBGT)
BehavioralParticipants 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
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: NRT Gum OnlyExperimental treatment 1 intervention
Group B: CBGT OnlyExperimental treatment 1 intervention
Group C: CBGT + NRT GumExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 weeks2
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 weeks3
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 periodSponsors and contacts
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Source ClinicalTrials.gov
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