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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Smoking Cessation
• Intervention / Treatment: Behavioral: Standard Web-based Smoking Cessation; Behavioral: Alcohol-focused Web-Based Smoking Cessation

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Center for Alcohol and Addiction Studies, Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Truth Initiative

Publications and helpful links

General Publications

• Kahler CW, Cohn AM, Costantino C, Toll BA, Spillane NS, Graham AL. A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e7570. doi: 10.2196/formative.7570.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: R34AA024593 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No