Last reviewed · How we verify

NCT04286867: ALCMOD

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

Completed Phase 1, PHASE2 Results posted Last updated 18 November 2024
What this trial tests

Phase 1, PHASE2 trial testing Alcohol Moderation Mobile Application in Alcohol Abuse in 64 participants. Completed in 10 May 2022.

Timeline
5 February 2020
Primary endpoint
10 May 2022
10 May 2022

Quick facts

Lead sponsorKent State University
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment64
Start date5 February 2020
Primary completion10 May 2022
Estimated completion10 May 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kent State University

Who can join

21 and older, any sex, with Alcohol Abuse or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Young Adult Alcohol Consequences Questionnaire Primary · 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

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.

GroupValue95% CI
Alcohol Moderation Group 1-4.48± 4.07
Alcohol Moderation Group 2-4.63± 3.97
Number of Standard Drinks Consumed Per Drinking Day Primary · 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline

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).

GroupValue95% CI
Alcohol Moderation Group 1-.618± 1.81
Alcohol Moderation Group 2-.955± 2.21

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Alcohol Abuse

Currently open trials in the same condition.

Other Kent State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04286867.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing