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

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ClinicalTrials.gov Identifier: NCT03068611
Recruitment Status : Completed
First Posted : March 3, 2017
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Truth Initiative
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Alcohol Drinking Behavioral: Standard Web-based Smoking Cessation Behavioral: Alcohol-focused Web-Based Smoking Cessation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month [ Time Frame: 1 month after enrollment ]
    Self-report abstinence from smoking

  2. Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months [ Time Frame: 6 months after enrollment ]
    Self-report abstinence from smoking

  3. Number of Heavy Drinking Days at 1 Month [ Time Frame: 1 month after enrollment ]
    Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men

  4. Number of Heavy Drinking Days at 6 Months [ Time Frame: 6 months after enrollment ]
    Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068611


Locations
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United States, Rhode Island
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Truth Initiative
  Study Documents (Full-Text)

Documents provided by Christopher W. Kahler, Brown University:
Statistical Analysis Plan  [PDF] August 23, 2019
Study Protocol  [PDF] January 8, 2016


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Responsible Party: Christopher W. Kahler, Professor, Brown University
ClinicalTrials.gov Identifier: NCT03068611     History of Changes
Other Study ID Numbers: R34AA024593 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs