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Search / Trial NCT07075575

Quit-Smoking Study for Native Hawaiians

Launched by UNIVERSITY OF HAWAII · Jul 10, 2025

Trial Information

Current as of September 09, 2025

Not yet recruiting

Keywords

Native Hawaiian Smoking Cessation Nicotine Replacement Therapy Nicotine Gum

ClinConnect Summary

This study is designed to help Native Hawaiian adults who want to quit smoking by testing two common methods: nicotine gum and group counseling. Participants will be placed into one of three groups—using nicotine gum alone, attending group counseling sessions alone, or doing both together. The study will take place at certain public housing locations on O'ahu, and the researchers want to find out which approach works best to help people stop smoking and is most acceptable in this community.

To join, you need to be between 18 and 80 years old, identify as fully or partly Native Hawaiian, currently smoke at least 5 cigarettes a day, and live in one of three specific public housing areas (Kalihi Valley Homes, Kuhio Park Terrace, or Mayor Wright Housing). Participants must be ready to try quitting smoking right after the first visit and agree to only use the treatments given by the study team during the 12 weeks, avoiding other tobacco, nicotine products, cannabis, or drugs during this time. If eligible and enrolled, you’ll receive either nicotine gum, group counseling, or both, and the researchers will support you as you try to quit smoking to see which method helps the most.

Gender

ALL

Eligibility criteria

  • 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

About University Of Hawaii

The University of Hawaii is a leading research institution committed to advancing medical science and improving health outcomes through innovative clinical trials. With a diverse team of experienced researchers and access to a wide range of resources, the university fosters collaborative initiatives that aim to address pressing health challenges. By integrating cutting-edge technology and multidisciplinary expertise, the University of Hawaii conducts rigorous clinical research to enhance understanding of various medical conditions, ultimately contributing to the development of effective therapies and interventions for diverse populations.

Locations

Honolulu, Hawaii, United States

Patients applied

0 patients applied

Trial Officials

Crissy T Kawamoto

Study Director

University of Hawai'i Cancer Center

Pallav Pokhrel, PhD, MPH

Principal Investigator

University of Hawai'i Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported