Quit-Smoking Study for Native Hawaiians

NCT07075575 | Not Yet Recruiting DMC

• 1 other identifier: POKHREL-2024-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Native Hawaiian; Smoking cessation; Nicotine replacement therapy; Nicotine gum; Cigarette Smoking; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• 7-day point prevalence abstinence (PPA)

  Self-reported 7-day point prevalence abstinence from cigarette smoking, confirmed by exhaled carbon monoxide (eCO) \<10 ppm at final follow-up visit.

  12 weeks after baseline (Study Visit 8)

Secondary Outcomes (3)

• Change in nicotine dependence

  Baseline to 12 weeks

• Change in smoking self-efficacy

  Baseline to 12 weeks

• Number of adverse events

  Throughout the 12-week intervention period

Study Arms (3)

NRT Gum Only

EXPERIMENTAL

Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided.

Drug: Nicotine Polacrilex Gum (2 mg)

CBGT Only

EXPERIMENTAL

Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided.

Behavioral: Cognitive Behavioral Group Therapy (CBGT)

CBGT + NRT Gum

EXPERIMENTAL

Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation.

Drug: Nicotine Polacrilex Gum (2 mg); Behavioral: Cognitive Behavioral Group Therapy (CBGT)

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

CBGT + NRT Gum; NRT Gum Only

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

CBGT + NRT Gum; CBGT Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

University of Hawai'i

Honolulu, Hawaii, 96813, United States

Location

Related Publications (17)

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Related Links

• General consumer information about nicotine gum, including proper use, precautions, and side effects. Provided by MedlinePlus, a service of the U.S. National Library of Medicine.
• Strategic plan from the Hawai'i State Department of Health outlining goals and priorities for tobacco prevention and control across the state, including culturally tailored interventions for Native Hawaiians and other priority populations.
• Behavioral Risk Factor Surveillance System (BRFSS) data from the Hawai'i Health Data Warehouse showing smoking prevalence among adults by race/ethnicity from 2018-2023. Useful for understanding disparities in tobacco use among Native Hawaiians and other
• Summary report from the Hawai'i Tumor Registry presenting cancer incidence and mortality data in Hawai'i from 2014-2018. Includes statistics by race/ethnicity and geographic region, supporting local relevance of tobacco-related cancer prevention.
• ICH E2A guideline outlining international standards for defining, collecting, and reporting clinical safety data, including serious adverse events (SAEs) and expedited reporting procedures.
• Guidelines from the National Cancer Institute (NCI) detailing adverse event reporting requirements for investigators conducting studies under NCI's Division of Cancer Treatment and Diagnosis (DCTD) and Division of Cancer Prevention (DCP) INDs and IDEs.
• Official NCI Thesaurus entry for "Nicotine Dependence," providing standardized terminology and coding used in biomedical research and clinical trial reporting.
• National Cancer Institute fact sheet offering practical guidance for managing nicotine withdrawal symptoms and behavioral triggers when quitting tobacco. Intended for patients and healthcare providers.
• The 2014 Surgeon General's Report summarizes 50 years of scientific evidence on the health effects of smoking. It provides comprehensive data on smoking-related diseases, tobacco use patterns, and public health impact in the U.S.

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Cigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Study Officials

• Crissy T Kawamoto

  University of Hawai'i Cancer Center

  STUDY DIRECTOR

• Pallav Pokhrel, PhD, MPH

  University of Hawai'i Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pallav Pokhrel, PhD, MPH

CONTACT

808-441-7711; ppokhrel@cc.hawaii.edu

Yoko Takahashi, MD

CONTACT

8086926501; ytakahashi@cc.hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)