N/A
N=119
Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Smoking Cessation · Alcohol Drinking
Bottom Line
View on ClinicalTrials.gov: NCT03068611 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month — 10; 10 Participants — p=.90
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Web-based Smoking Cessation (Behavioral); Alcohol-focused Web-Based Smoking Cessation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month |
10; 10 | .90 |
| PRIMARY Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months |
9; 11 | .54 |
| PRIMARY Number of Heavy Drinking Days at 1 Month |
2.9; 4.4 | .36 |
| PRIMARY Number of Heavy Drinking Days at 6 Months |
2.6; 3.8 | .92 |
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.
Eligibility Criteria
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;
Data sourced from ClinicalTrials.gov (NCT03068611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.