Quit-Smoking Study for Native Hawaiians

University of Hawaii

Status: Enrolling

Conditions: Tobacco Use Disorder; Smoking Cessation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07075575

POKHREL-2024-1

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

NRT Gum Only

Experimental group

Description:

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

Treatment:

Drug: Nicotine Polacrilex Gum (2 mg)

CBGT Only

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Group Therapy (CBGT)

CBGT + NRT Gum

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Group Therapy (CBGT)

Drug: Nicotine Polacrilex Gum (2 mg)