ClinicalTrials.gg
CompletedNCT04286867ALCMODUpdated Nov 18, 2024Results posted

Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies

A Phase 1/2 interventional study of Alcohol Moderation Mobile Application and Alcohol Moderation Drink Tracker in Alcohol Abuse, Alcohol Use Disorder and Alcohol Abuse, Episodic, sponsored by Kent State University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by Kent State University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Alcohol Abuse
  • Alcohol Use Disorder
  • Alcohol Abuse, Episodic
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's enrollment of 64 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Kent State University is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. must report experiencing at least three negative consequences of alcohol use in the past month (assessed via Brief Young Adult Alcohol Consequences Questionnaire: BYAACQ)
  2. have access to a smartphone
  3. endorse importance in changing their drinking (2 or greater on Alcohol Ladder Scale Importance to Change)
  4. report having consumed at least 5 drinks (for men) or 4 drinks (for women) on one or more occasions in the past 2-weeks

Exclusion criteria

Exclusion Criteria:

  1. seeking treatment for alcohol use from a health-care provider
  2. younger than age 21
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Alcohol Moderation Group 1

    This group will receive a link and in-person instructions on how to use the alcohol moderation application described. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

    Other: Alcohol Moderation Mobile Application

  • Active comparator
    Alcohol Moderation Group 2

    This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

    Behavioral: Alcohol Moderation Drink Tracker

Interventions

  • OtherAlcohol Moderation Mobile Application

    This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

  • BehavioralAlcohol Moderation Drink Tracker

    This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

06

What researchers measure

Primary outcomes

  1. The Young Adult Alcohol Consequences Questionnaire

    The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) will be used to assess negative consequences of alcohol use (24-items). Minimum score is 0, maximum is 24, with higher scores indicating more negative consequences of alcohol use.

    Time frame: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

  2. Number of Standard Drinks Consumed Per Drinking Day

    A daily alcohol use diary will be provided for the two-week observation period. Participants will be trained on how to use the diary during the baseline laboratory session. Number of standard drinks per drinking day will be calculated from the daily diary alcohol consumption records (total number of standard drinks consumed / number of drinking days).

    Time frame: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

07

Results

Posted Nov 18, 2024

Participant flow

Participant flow — Overall Study
MilestoneAlcohol Moderation Group 1Alcohol Moderation Group 2
Started3232
Completed2930
Not completed32

Outcome measures

PrimaryThe Young Adult Alcohol Consequences Questionnaire

The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) will be used to assess negative consequences of alcohol use (24-items). Minimum score is 0, maximum is 24, with higher scores indicating more negative consequences of alcohol use.

Time frame:
14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline
Reported as:
Mean · outcome score minus baseline score
The Young Adult Alcohol Consequences Questionnaire
outcome score minus baseline scoreAlcohol Moderation Group 1Alcohol Moderation Group 2
The Young Adult Alcohol Consequences Questionnaire-4.48 ± 4.07-4.63 ± 3.97
PrimaryNumber of Standard Drinks Consumed Per Drinking Day

A daily alcohol use diary will be provided for the two-week observation period. Participants will be trained on how to use the diary during the baseline laboratory session. Number of standard drinks per drinking day will be calculated from the daily diary alcohol consumption records (total number of standard drinks consumed / number of drinking days).

Time frame:
14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline
Reported as:
Mean · change in standard drinks
Number of Standard Drinks Consumed Per Drinking Day
change in standard drinksAlcohol Moderation Group 1Alcohol Moderation Group 2
Number of Standard Drinks Consumed Per Drinking Day-.618 ± 1.81-.955 ± 2.21

Adverse events

Collected over each participant was assessed for adverse events from the time of their consent to intitate the study until the end of the final outcome session in which assessments were collected, 14 days in total.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alcohol Moderation Group 10/29 (0%)0/29 (0%)0/29 (0%)
Alcohol Moderation Group 20/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Alcohol Moderation Group 1Alcohol Moderation Group 2Total
Mean37.11 ± 16.0538.41 ± 14.2537.77 ± 15.05
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Alcohol Moderation Group 1Alcohol Moderation Group 2Total
Identified Gender — Female232144
Identified Gender — Male5914
Identified Gender — Identified as another gender101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Alcohol Moderation Group 1Alcohol Moderation Group 2Total
Hispanic or Latino123
Not Hispanic or Latino282856
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Alcohol Moderation Group 1Alcohol Moderation Group 2Total
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American101
White272754
More than one race011
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)Alcohol Moderation Group 1Alcohol Moderation Group 2Total
United States293059
08

Study locations

1 site
  • Kent State University
    Kent, Ohio 44240, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04286867
Lead sponsor
Kent State University
Responsible party
William Lechner. PhD (Assistant Professor, Kent State University) — Principal investigator
First posted
Feb 27, 2020
Start date
Feb 5, 2020
Primary completion
May 10, 2022
Completion
May 10, 2022
Results posted
Nov 18, 2024
Last update
Nov 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion