NCT07075575

Quit-Smoking Study for Native Hawaiians

Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Hawaii · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tobacco Use Disorder
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine 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
BEHAVIORAL	Cognitive Behavioral Group Therapy (CBGT)	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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-01
• Completion: 2028-04-01
• First posted: 2025-07-20
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States