Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Completed · Not applicable
Conditions studied: Smoking Cessation, Alcohol Drinking
In brief
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.
Key facts
- Study ID
- NCT03068611
- Run by
- Brown University
- People needed
- 119
- Starts
- 2017-05-11
- Expected to finish
- 2018-04-30
- Last updated by the study team
- 2019-10-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
Where it is running
- Center for Alcohol and Addiction Studies, Brown University — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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