Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Number of Heavy Drinking Days at 1 Month
研究概览
简要总结
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
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 (Outcomes Assessor)
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 daily smoking of at least one cigarette per day
- •meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month)
- •age 18 or older
- •willingness to provide contact and mailing information following consent
排除标准
- •1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
研究组 & 干预措施
Standard Web-based Smoking Cessation
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
干预措施: Standard Web-based Smoking Cessation (Behavioral)
Alcohol-focused Web-Based Smoking Cessation
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
干预措施: Alcohol-focused Web-Based Smoking Cessation (Behavioral)
结局指标
主要结局
Number of Heavy Drinking Days at 1 Month
时间窗: 1 month after enrollment
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
时间窗: 1 month after enrollment
Self-report abstinence from smoking
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
时间窗: 6 months after enrollment
Self-report abstinence from smoking
Number of Heavy Drinking Days at 6 Months
时间窗: 6 months after enrollment
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
次要结局
未报告次要终点
研究者
Christopher W. Kahler
Professor
Brown University
