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

NCT ID: NCT03068611

Last Updated: 2019-10-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard Web-based Smoking Cessation

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Alcohol-focused Web-Based Smoking Cessation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Truth Initiative

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Christopher W. Kahler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Alcohol and Addiction Studies, Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32348286 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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R34AA024593

Identifier Type: NIH

Identifier Source: org_study_id

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