MedTrace Logo

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

NCT03068611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-10-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Smoking Cessation
  • Alcohol Drinking

Interventions

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.

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.

Sponsors & Collaborators

  • Truth Initiative

    collaborator OTHER

  • Brown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2018-04-01
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068611 on ClinicalTrials.gov