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

Brown University

Status: Completed

Conditions: Smoking Cessation; Alcohol Drinking

Treatments: Behavioral: Alcohol-focused Web-Based Smoking Cessation; Behavioral: Standard Web-based Smoking Cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT03068611

R34AA024593

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. current daily smoking of at least one cigarette per day
2. 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)
3. age 18 or older
4. willingness to provide contact and mailing information following consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

Standard Web-based Smoking Cessation

Active Comparator group

Description:

A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.

Treatment:

Behavioral: Standard Web-based Smoking Cessation

Alcohol-focused Web-Based Smoking Cessation

Experimental group

Description:

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.

Treatment:

Behavioral: Alcohol-focused Web-Based Smoking Cessation