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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2017年5月11日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Smoking Cessation
发起方
Brown University
入组人数
119
试验地点
1
主要终点
Number of Heavy Drinking Days at 1 Month
状态
已完成
最后更新
6年前

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.

注册库
clinicaltrials.gov
开始日期
2017年5月11日
结束日期
2018年4月30日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Christopher W. Kahler

Professor

Brown University

入排标准

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

  • history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;

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

研究点 (1)

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