A Pilot Pragmatic RCT of a Hospital-based Precision Pharmacotherapy Smoking Cessation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Participants Who Achieve Smoking Cessation
研究概览
简要总结
The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.
详细描述
Promising new evidence suggests that applying a precision pharmacotherapy approach based on the nicotine metabolite ration (NMR), a commercially available, genetically-informed marker of nicotine metabolism rate can significantly improve cessation outcomes. Evidence from multiple independent studies, including a recent randomized clinical trial (RCT), demonstrates that matching slow metabolizers of nicotine with the nicotine patch and fast metabolizers of nicotine with varenicline can maximize treatment response and minimize side effects. While encouraging, a critical gap in knowledge is how to best translate a precision pharmacotherapy approach into a hospital-based smoking cessation intervention and improve cessation rates for underserved smokers. Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the scientific premise of this application is that integrating a precision pharmacotherapy approach into a hospital-based smoking cessation program will increase medication uptake and effectiveness, with particular relevance for smokers from underserved communities.
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
- 是
入选标准
- •current smoker (5+ cigarettes/day)
- •patient at the Helen F. Graham Cancer Center & Research Institute (ChristianaCare) lung/thoracic clinic
排除标准
- •use of non-cigarette tobacco products or smoking cessation treatment
- •psychiatric or other medical contraindications to receiving smoking cessation medication
- •no telephone
- •medical instability
- •inability to communicate in English
- •unable to consent due to mental status
- •estimated life expectancy of <6 months
- •not a Delaware resident
- •pregnancy
研究组 & 干预措施
Treatment Plan Option 1 (Standard Care)
Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication.
干预措施: Standard Care (Behavioral)
Treatment Plan Option 2 (Precision Pharmacotherapy)
Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication.
干预措施: Precision pharmacotherapy (Behavioral)
结局指标
主要结局
Number of Participants Who Achieve Smoking Cessation
时间窗: 4-week follow-up
Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated.
次要结局
- Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)(4-week follow-up)
- Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)(1-week follow-up)
- Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile(1-week follow-up)
研究者
Scott Siegel
Director of Population Health Research
Christiana Care Health Services