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临床试验/NCT03068611
NCT03068611已完成不适用

Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation

Brown University1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2017年5月11日最近更新:
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
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

Active Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher W. Kahler

Professor

Brown University

研究点 (1)

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