Comparing Three Multicomponent Interventions to Help Adults Quit Smoking
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,550
- 试验地点
- 5
- 主要终点
- Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
研究概览
简要总结
The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.
详细描述
Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke.
Secondary Objectives:
- Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD)
- Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes.
- Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identify as Black
- •smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
- •motivated to quit smoking
- •willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
排除标准
- •currently taking bupropion for non-smoking cessation reasons
研究组 & 干预措施
Intensive Incentivized Intervention
The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
干预措施: Counseling Sessions (Other)
Standard Intervention
The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.
干预措施: Quitline Counseling Phone Calls (Other)
Intensive Intervention
The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content.
干预措施: Nicotine patch (Drug)
Standard Intervention
The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.
干预措施: Nicotine patch (Drug)
Intensive Intervention
The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content.
干预措施: Counseling Sessions (Other)
Intensive Intervention
The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content.
干预措施: Pathways to Freedom (Other)
Intensive Incentivized Intervention
The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
干预措施: Monetary Incentive (Other)
Intensive Incentivized Intervention
The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
干预措施: Pathways to Freedom (Other)
Intensive Incentivized Intervention
The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
时间窗: 26 weeks post-TQD
The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng/ml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD
次要结局
- Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day(26 weeks post-TQD)
- Treatment Satisfaction(8 weeks post-TQD)
- Cigarettes per day(baseline, 8 and 26 weeks post-TQD)
- Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)(baseline, 8 and 26 weeks post-TQD)
- Money spent on cigarettes per week(baseline, 8 and 26 weeks post-TQD)
- Smoking Cessation Self-efficacy using a single 10-point Likert scale(baseline, 8 and 26 weeks post-TQD)
- Psychological Distress measured by the 6-item Kessler screener (K6)(baseline, 8 and 26 weeks post-TQD)