Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- smoking, self-report
研究概览
简要总结
The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app.
详细描述
The primary goal of the current study will be to evaluate the use of a new smart phone application (app; Stay Quit Coach) in preventing relapse to smoking among individuals with PTSD. The enhanced technology intervention will combine mobile contingency management (mCM), guideline-based smoking cessation counseling, bupropion and nicotine replacement therapy (NRT), and use of the Stay Quit Coach. For this study, we will propose a clinical trial with a two-group design in which 20 smokers with PTSD will be randomized to either:
QUIT4EVER, an intervention that combines guideline-based smoking cessation counseling, bupropion and NRT, mCM and Stay Quit Coach.
COMBINED CONTACT CONTROL (CCC) an intervention that is identical to QUIT4EVER except Stay Quit Coach will not be included. The CCC controls for compensation, monitoring, time and attention effects.
Specific aims are to:
AIM 1: evaluate the efficacy of QUIT4EVER on rates of abstinence from cigarettes (assessed with multiple measures including bioverified abstinence) during short and long term abstinence (measured at 3 and 6 months).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for current PTSD;
- •Has current smoking status of at least 10 cigarettes per day (verified with breath carbon monoxide measurement);
- •Has been smoking for at least 1 year;
- •Is aged 18 to 70;
- •Can speak and write current fluent conversation English; and
- •Is willing to make a smoking cessation attempt.
排除标准
- •Is pregnant;
- •Has diagnosis, based on DSM-IV criteria, of schizophrenia, schizophreniform disorder, schizoaffective disorder, current psychotic symptoms, delusional disorder, current (not in remission) substance use disorder, and/or current manic episode;
- •Will not be stable on medications for the study period;
- •Has history of myocardial infarction in past 6 months;
- •Uses any other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use during study period; or
- •Is currently imprisoned.
- •Note: Participants may be excluded or asked to refrain from taking certain study medications if they have a seizure disorder, uncontrolled diabetes, an eating disorder, or current or past cirrhosis or hepatitis.
研究组 & 干预措施
QUIT4Ever
QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach.
干预措施: Smoking cessation counseling (Other)
Control Contact Condition
This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
干预措施: Bupropion (Drug)
QUIT4Ever
QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach.
干预措施: Stay Quit Coach (Other)
QUIT4Ever
QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach.
干预措施: nicotine replacement therapy (Drug)
QUIT4Ever
QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach.
干预措施: mobile contingency management (Behavioral)
Control Contact Condition
This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
干预措施: Smoking cessation counseling (Other)
Control Contact Condition
This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
干预措施: mobile contingency management (Behavioral)
Control Contact Condition
This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
干预措施: nicotine replacement therapy (Drug)
QUIT4Ever
QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach.
干预措施: Bupropion (Drug)
结局指标
主要结局
smoking, self-report
时间窗: 6 months follow-up
Participants' self-report of smoking in the past seven days will be measured at the end of the treatment intervention, and at 3 and 6-month follow-up contacts.
次要结局
- saliva cotinine(6 months)