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Integrated Digital Intervention for Alcohol Use Disorder

NCT05748639 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-11-20

No results posted yet for this study

Summary

This study is a two-arm randomized clinical trial comparing the Quit Genius intervention for alcohol use disorder (QG-A) to usual care (TAU), comprising medical management of alcohol use disorders with pharmacotherapy. Participants (N=300) will be randomly assigned to either QG-A or TAU, and will be assessed at baseline, monthly throughout the 6-month intervention phase and at 3 and 6 months post-treatment, to investigate the impact of QG-A, relative to TAU on alcohol use, psychological symptoms, and health service utilization. The primary aim of the study is to evaluate the efficacy of QG-A, relative to TAU in reducing alcohol use and associated mental health and functional outcomes. A secondary aim is to examine the cost-effectiveness of QG-A, including cost savings and impact on productivity.

Conditions

Interventions

OTHER

Medical Management

Participants randomized to receive the MM (Control) intervention will receive monthly appointments with a medical provider and access to naltrexone.

OTHER

Mobile health application

Participants randomized to receive the QG-A (Experimental) intervention will receive monthly appointments with a medical provider, access to naltrexone, and weekly and bi-weekly appointments with a licensed clinical counselor through an integrated digital health application.

Sponsors & Collaborators

  • Quit Genius

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-06-15
Completion
2025-07-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748639 on ClinicalTrials.gov