Quit-Smoking Study for Native Hawaiians (NCT07075575) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Quit-Smoking Study for Native Hawaiians
United States75 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
What they're measuring
1
7-day point prevalence abstinence (PPA)
Timeframe: 12 weeks after baseline (Study Visit 8)