Quit-Smoking Study for Native Hawaiians

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
University of Hawaii
Study ID
NCT07075575
Status
Not Yet Recruiting

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Conditions

  • Smoking Cessation
  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicotine Polacrilex Gum (2 mg) — DRUG
    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
  • Cognitive Behavioral Group Therapy (CBGT) — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NRT Gum Only
    Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided.
  • Experimental: CBGT Only
    Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided.
  • Experimental: CBGT + NRT Gum
    Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation.

Primary Outcome Measure

7-day point prevalence abstinence (PPA) [ Time Frame: 12 weeks after baseline (Study Visit 8) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Hawai'iHonoluluHawaii96813
Pallav Pokhrel, PhD, MPH
[email protected]
8084417711

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By research site
University of Hawai'i· Honolulu, HI

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