NCT02367391已完成不适用
Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Sustained Abstinence at the 12-week Follow up
研究概览
简要总结
This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.
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 (Investigator)
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
- •Smoke >4 cigarettes/day for at least 6 months
- •Want to quit and ready to try in next 30 days
- •Willing to quit all forms of tobacco (including e-cigs)
- •Willing to use Chantix to try to quit
- •Have a cell phone able to receive text messages
- •Willing to attend 3 visits and use varenicline for smoking cessation
- •Plan to live in local area for next 6 months
- •Read and write in English
- •Women not pregnant and taking steps to avoid
- •Able to understand and willing to sign consent
排除标准
- •History of allergic reaction or other adverse event while using varenicline
- •Used a smoking cessation aid/medicine in past 1 month (including e-cigs)
- •Currently pregnant or nursing
- •Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts
- •Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months
- •Uses non-cigarette tobacco products and does not plan to quit all tobacco.
- •Has a history of kidney problems or receives dialysis
- •Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks
- •Had a heart attack in the past 4 weeks
- •Mental conditions that would prohibit the participant from completing the protocol
研究组 & 干预措施
Motivational Text Messages
Experimental
干预措施: Motivational Text Messages (Behavioral)
Control
Sham Comparator
干预措施: Control (Behavioral)
结局指标
主要结局
Sustained Abstinence at the 12-week Follow up
时间窗: 12 weeks
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
时间窗: 12 weeks
Number of Days of Varenicline Use
时间窗: 12 weeks
Number of Active Smoking Cessation Activities Used
时间窗: 12 weeks
Number of activities completed out of 6
次要结局
- Time (in Days) to Relapse After the Target Quit Day(12 weeks)
- Total Score on the Positive Smoking Cessation Activities Measure(12 weeks)
- Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.(12 weeks)
研究者
Jonathan Foulds
Professor
Milton S. Hershey Medical Center
研究点 (1)
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