Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure:
研究概览
简要总结
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
详细描述
The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65
- •Smokes at least 5 cigarettes daily
- •Is interested in quitting in the next 30 days
- •Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
- •Willing and able to receive SMS text messages
- •Able to comprehend the English-language and the informed consent form
- •Lives in the United States
- •One half of the study sample will be recruited from the general population of smokers via social media advertisements
- •One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network
排除标准
- •Prior use of Clickotine or QuitGuide
- •Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
研究组 & 干预措施
Treatment A (device Clickotine®)
User will open and use Treatment A (Clickotine® device) several times a day up to their quit date to complete a program of 21 Missions.
干预措施: Treatment A with device Clickotine® (Active intervention) (Device)
Treatment B (smoking education)
Treatment B app provides education and support to smokers seeking to quit. When a user has a craving or wants support or education, they can log into the app.
干预措施: Treatment B with smoking education (control) (Device)
结局指标
主要结局
Primary Outcome Measure:
时间窗: [Time Frame: 8 week core study]
The primary objective is to confirm the improved efficacy of CKT for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs. QuitGuide. \*\*Acceptance criteria: Self-reported 30 day point prevalence quit rates will be significantly higher in the CKT arm than QuitGuide.
次要结局
- Secondary Outcome Measure([Time Frame: 8 week core study])