Smoking Cessation, Tobacco Use Disorder
Conditions
Keywords
Native Hawaiian, Smoking cessation, Nicotine replacement therapy, Nicotine gum, Cigarette Smoking, Tobacco Dependence
Brief 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.
Interventions
DRUGNicotine 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
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
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Affiliated with one of three (3) designated public housing complexes at which the intervention will be delivered: Kalihi Valley Homes, Kuhio Park Terrace, Mayor Wright Housing * Willing to make a smoking cessation attempt the day after the first study visit (i.e., date of consent) * Willing to engage in use of nicotine replacement therapy gum (NRT gum) and/or smoking cessation-focused cognitive-behavioral group therapy (CBGT) * Participant must agree to not use any form of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking during the 12-week study period, except as specifically assigned to his or her study condition and distributed by the research team * Participant must agree to not use other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) during the 12-week study period * Participant must agree to not smoke or vape cannabis (i.e., marijuana) during the 12- week study period * Participant must agree to not use other illicit drugs, including prescription opioid medications, during the 12-week study period * Participant must be able to speak, read, and write English * Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
Exclusion criteria
* 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 * Use of other illicit drugs, including prescription opioid medications, in the 30 days prior to eligibility screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence (PPA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in nicotine dependence | Baseline to 12 weeks | Change in nicotine dependence scores as measured by standardized tools (e.g., Fagerström Test for Nicotine Dependence). |
| Change in smoking self-efficacy | Baseline to 12 weeks | Change in participants' confidence in their ability to quit smoking, measured using a validated smoking self-efficacy scale. |
| Number of adverse events | 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. |
Countries
United States
Contacts
CONTACTPallav Pokhrel, PhD, MPH
CONTACTYoko Takahashi, MD
STUDY_DIRECTORCrissy T Kawamoto
University of Hawai'i Cancer Center
PRINCIPAL_INVESTIGATORPallav Pokhrel, PhD, MPH
University of Hawai'i Cancer Center
Outcome results
None listed