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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068611
• Other study ID #: R34AA024593
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: September 2019
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 30, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Alcohol Drinking
• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Alcohol and Addiction Studies, Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month	Self-report abstinence from smoking	1 month after enrollment
Primary	Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months	Self-report abstinence from smoking	6 months after enrollment
Primary	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
Primary	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