At a glance
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Randomized Controlled Trial of an Integrated Digital Cognitive-Behavioral Therapy (CBT) and Pharmacotherapy Intervention for Adults With Alcohol Use Disorders
In Brief
A Phase 3 clinical trial evaluating Mobile health application and Medical Management for Alcohol Use Disorder. Completed, enrolled 242 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
Participants randomized to receive the MM (Control) intervention will receive monthly appointments with a medical provider and access to naltrexone.