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Completed

NCT Number: NCT03068611

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.

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Key information

Conditions

Smoking Cessation Alcohol Drinking Behavior Drinking Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Alcohol and Addiction Studies, Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;

Treatment and study plan

Standard Web-based Smoking Cessation

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

Behavioral

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Truth Initiative

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2017
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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