Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04286867 |
| Other study ID # |
18-199 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 5, 2020 |
| Est. completion date |
May 10, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Kent State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aims of the study are to assess the user experience and initial efficacy of a
mobile application designed to reduce problematic alcohol use. The application utilizes
drinking limits, defined by the user, to pace alcohol consumption during drinking occasions.
The mobile application will be compared to strategies for tracking drinking detailed within
the National Institute on Alcohol Abuse and Alcoholism Alcohol Moderation Strategies
(https://www.rethinkingdrinking.niaaa.nih.gov/thinking-about-a-change/strategies-for-cutting-
down/tips-to-try.aspx). Primary outcome variables, in addition to variables assessing user
design experience of the application and use of moderation strategies, include (1) negative
consequences of alcohol use during a 14 day observation period, and (2) number of drinks
consumed per drinking day during a 14 day observation period.
Description:
The mobile application to be tested provides guidance on moderating alcohol use in real time
based on individual user's pre-defined drinking limits. This mobile application will be
compared to a drink tracking strategy and corresponding tool outlined within the National
Institute on Alcohol Abuse and Alcoholism Alcohol Moderation Strategies
(https://www.rethinkingdrinking.niaaa.nih.gov/thinking-about-a-change/strategies-for-cutting-
down/tips-to-try.aspx).
Participants will be recruited from the community in Northeastern Ohio. Eligible participants
will meet the following inclusion criteria 1) be age 21 or older, 2) report experiencing at
least three negative consequence of alcohol use in the past month (assessed via Brief Young
Adult Alcohol Consequences Questionnaire: BYAACQ), 3) report having consumed at least 5
drinks (for men) or 4 drinks (for women) on one or more occasions in the past 2-weeks, 4) not
be seeking treatment for alcohol use from a health-care provider, and 5) have access to a
smartphone and 6) endorse some importance in changing their drinking (2 or greater on Alcohol
Ladder Scale Importance to Change). Participants who endorse seeking treatment for alcohol
related problems from a health care provider will be provided with a list of university
sponsored and community based treatment providers, and excluded. Participants (n=64) will
complete a battery of assessments including demographic measures, alcohol and substance use
measures, psychological measures, behavioral economic and neuropsychological measures.
The Timeline Follow-back Interview will be used to assess alcohol use. The Brief Young Adult
Alcohol Consequences Questionnaire (BYAACQ ) will be used to assess a range of negative
consequences of alcohol use that young adults may experience (e.g., while drinking in the
past month, I have said or done embarrassing things).
Following this initial baseline assessment, participants will be randomized to one of two
experimental conditions detailed below (Alcohol Moderation Group 1 and 2). Doctoral
Candidates in Clinical Psychology will review strategies for moderating alcohol use with all
participants (strategies recommended by the National Institute on Alcohol Abuse and
Alcoholism; detail included as supplement). The only variation in the discussion of
strategies is the the Alcohol Moderation Group 1 will receive detail and training on how to
use the mobile application; whereas, the Alcohol Moderation Group 2 will receive detail and
training on how to use the drinking tracker card recommended within the NIAAA guidelines.
Primary outcome variables, in addition to variables assessing user design experience of the
application and use of moderation strategies, will include (1) negative consequences of
alcohol use during a 14 day observation period following randomization, and (2) number of
drinks consumed per drinking day during a 14 day observation period following randomization.
Assessment of primary outcome variable (1) will include baseline negative consequences of
alcohol use (BYAACQ score) during the 14 day period prior to randomization as a covariate as
well as additional covariates defined a priori based on the extant literature. Assessment of
primary outcome variable (2) will include consideration of average drinking limit for each
drinking day defined by the user, and number of drinks per drinking day in a 14 day period
prior to randomization, as well as covariates defined a priori based on the extant
literature.
