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

Primary Purpose

Smoking Cessation, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Web-based Smoking Cessation
Alcohol-focused Web-Based Smoking Cessation
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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;

Sites / Locations

  • Center for Alcohol and Addiction Studies, Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Web-based Smoking Cessation

Alcohol-focused Web-Based Smoking Cessation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
Self-report abstinence from smoking
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
Self-report abstinence from smoking
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
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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2017
Last Updated
September 16, 2019
Sponsor
Brown University
Collaborators
Truth Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT03068611
Brief Title
Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Official Title
Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
Truth Initiative

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Alcohol Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Web-based Smoking Cessation
Arm Type
Active Comparator
Arm Description
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Arm Title
Alcohol-focused Web-Based Smoking Cessation
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Web-based Smoking Cessation
Intervention Description
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol-focused Web-Based Smoking Cessation
Intervention Description
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Primary Outcome Measure Information:
Title
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
Description
Self-report abstinence from smoking
Time Frame
1 month after enrollment
Title
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
Description
Self-report abstinence from smoking
Time Frame
6 months after enrollment
Title
Number of Heavy Drinking Days at 1 Month
Description
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Time Frame
1 month after enrollment
Title
Number of Heavy Drinking Days at 6 Months
Description
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
Center for Alcohol and Addiction Studies, Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32348286
Citation
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.
Results Reference
derived

Learn more about this trial

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

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