High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Dual use abstinence
研究概览
简要总结
This randomized clinical trial evaluates the effectiveness of augmented-dose combination nicotine replacement therapy (NRT) versus standard-dose NRT and no-NRT control for cessation of dual combustible cigarette (CC) and electronic cigarette (EC) use. Adults who currently engage in dual use and are motivated to quit both products will be assigned to one of three 12-week interventions: (1) no pharmacotherapy (behavioral support only), (2) standard-dose NRT (21 mg nicotine patch + 4 mg lozenges, 5-20/day), or (3) augmented-dose NRT (21 mg + 14 mg patches + 4 mg lozenges, 5-30/day). All groups receive evidence-based behavioral support through the EX Program. Primary outcomes include biochemically confirmed dual abstinence and CC-only abstinence at 12 and 24 weeks. A subset of participants will provide blood and saliva samples to assess DNA damage biomarkers associated with tobacco use and cessation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •report nicotine-containing e-cigarette use 5+ times per day, >5 days per week, for > 6 months;
- •smoking >1 cigarette per day, >5 days per week, for >6 months;
- •interest in quitting cigarettes and e-cigarettes within the next month (>6 on 10-point scale);
- •willing to try nicotine replacement therapy;
- •access to text/internet/email.
排除标准
- •report use of other tobacco or nicotine products (i.e., pouches, smokeless tobacco, hookah) >1 time per week in the past 3 months;
- •have medical contraindications for nicotine replacement therapy use (patch and lozenge; e.g., recent myocardial infarction, arrhythmias, angina, vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated such as PKU);
- •report current use of smoking cessation medications (varenicline, bupropion, other nicotine replacement therapies);
- •endorse symptoms of Cannabis Use Disorder (using the CUDIT assessment);
- •unable to consent (e.g., cognitive deficit, non-English speaking);
- •live outside the US.
研究组 & 干预措施
Standard dose NRT
Participants will receive a standard dose of nicotine replacement therapy (NRT).
干预措施: Nicotine Replacement Therapy (NRT, nicotine patch) (Drug)
High dose NRT
Participants will receive a higher dose of NRT than what is typically used.
干预措施: Text- and web-based support (Behavioral)
Behavioral Support
Participants will receive behavioral support only.
干预措施: Text- and web-based support (Behavioral)
Standard dose NRT
Participants will receive a standard dose of nicotine replacement therapy (NRT).
干预措施: Text- and web-based support (Behavioral)
High dose NRT
Participants will receive a higher dose of NRT than what is typically used.
干预措施: Nicotine Replacement Therapy (NRT, nicotine patch) (Drug)
High dose NRT
Participants will receive a higher dose of NRT than what is typically used.
干预措施: Nicotine replacement therapy lozenge (Drug)
Standard dose NRT
Participants will receive a standard dose of nicotine replacement therapy (NRT).
干预措施: Nicotine replacement therapy lozenge (Drug)
结局指标
主要结局
Dual use abstinence
时间窗: Week 12, Week 24
7-day point prevalence biochemically-confirmed abstinence from both e-cigarettes and cigarettes. E-cigarette abstinence is based on self-report and cotinine (if no longer using NRT) and cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation. Non-responders and missing data will be coded as not abstinent.
Cigarette abstinence
时间窗: Weeks 12, Week 24
7-day point prevalence biochemically-confirmed abstinence from cigarettes (and still using e-cigarettes). Cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation. Non-responders and missing data will be coded as not abstinent.
次要结局
未报告次要终点
研究者
Amanda Palmer
Assistant Professor-Faculty
Medical University of South Carolina