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NCT Number: NCT07075575

Quit-Smoking Study for Native Hawaiians

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawai'i

Honolulu, Hawaii, 96813, United States

Location contact

Pallav Pokhrel, PhD, MPH

CONTACT

[email protected]

8084417711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 7-day point prevalence abstinence (PPA)

    Time frame: 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 outcomes

  1. Change in nicotine dependence

    Time frame: Baseline to 12 weeks

    Change in nicotine dependence scores as measured by standardized tools (e.g., Fagerström Test for Nicotine Dependence).

  2. Change in smoking self-efficacy

    Time frame: Baseline to 12 weeks

    Change in participants' confidence in their ability to quit smoking, measured using a validated smoking self-efficacy scale.

  3. Number of adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pallav Pokhrel, PhD, MPH

CONTACT

[email protected]

808-441-7711

Yoko Takahashi, MD

CONTACT

[email protected]

8086926501

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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