Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 7-day point prevalence abstinence (PPA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NRT Gum Only
Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided.
干预措施: Nicotine Polacrilex Gum (2 mg) (Drug)
CBGT Only
Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided.
干预措施: Cognitive Behavioral Group Therapy (CBGT) (Behavioral)
CBGT + NRT Gum
Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation.
干预措施: Nicotine Polacrilex Gum (2 mg) (Drug)
CBGT + NRT Gum
Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation.
干预措施: Cognitive Behavioral Group Therapy (CBGT) (Behavioral)
结局指标
主要结局
7-day point prevalence abstinence (PPA)
时间窗: 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.
次要结局
- 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)