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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Smoking Cessation, Alcohol Drinking

Intervention / Treatment
-----------------
* Behavioral: Standard Web-based Smoking Cessation
* Behavioral: Alcohol-focused Web-Based Smoking Cessation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Web-based Smoking Cessation<br>A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | Behavioral: Standard Web-based Smoking Cessation<br>* A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.<br>|
| Experimental: Alcohol-focused Web-Based Smoking Cessation<br>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. | Behavioral: Alcohol-focused Web-Based Smoking Cessation<br>* A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month | Self-report abstinence from smoking | 1 month after enrollment | 
| Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months | Self-report abstinence from smoking | 6 months after enrollment | 
| Number of Heavy Drinking Days at 1 Month | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men | 1 month after enrollment | 
| Number of Heavy Drinking Days at 6 Months | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men | 6 months after enrollment |