Clinical trial NCT03068611: Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Official title: Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Alcohol Drinking
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Truth Initiative
First posted: 2017-03-03
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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;

Primary outcomes:
measure: Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
timeFrame: 1 month after enrollment
measure: Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
timeFrame: 6 months after enrollment
measure: Number of Heavy Drinking Days at 1 Month
timeFrame: 1 month after enrollment
measure: Number of Heavy Drinking Days at 6 Months
timeFrame: 6 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies, Brown University
state: Rhode Island
Study officials:
References:
citation: Kahler CW, Cohn AM, Costantino C, Toll BA, Spillane NS, Graham AL. A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e7570. doi: 10.2196/formative.7570.