NCT05748639

Integrated Digital Intervention for Alcohol Use Disorder

Randomized Controlled Trial of an Integrated Digital Cognitive-Behavioral Therapy (CBT) and Pharmacotherapy Intervention for Adults With Alcohol Use Disorders

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Quit Genius · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Effective and evidence-based therapies are available for management of Alcohol Use Disorder (AUD) with a variety of pharmacological and psychosocial interventions supported by a sizable clinical trials literature. However, a major barrier in addressing this significant public health issue is the fact that a majority of individuals with AUD are not receiving treatment. Evidence shows that Individuals with problematic alcohol use may be dissuaded from seeking help due to a lack of accessibility of services, stigmatization, low motivation, or cost of treatment. Traditional methods of treating AUD typically utilize a behavioral, pharmacological or a combination approach. Medication-assisted treatment (MAT) is the use of medications, in combination with psychosocial therapies, to provide an integrated approach to the treatment of substance use disorders. The MAT approach to treating AUD has been widely successful, with various combinations of pharmacotherapy and psychosocial interventions showing efficacy in the reduction of alcohol use. In particular, the combination of psychosocial therapies such as CBT, MET and 12 steps have proven highly successful when used in combination with the opioid receptor antagonist Naltrexone (NTX). Yet, a lack of accessibility, practicality and adherence to traditional methods has left many alcohol users without the means to effectively deal with their addictions. Digital therapeutics can address these issues and provide advantages including anonymity, convenience, accessibility, cost-effectiveness, and privacy. Digital therapies can also target individuals with problematic alcohol use who are in different psychological stages of change, allowing potential users to investigate treatment options without the stigma associated with face-to-face interactions. Additionally, these digitized evidence-based therapies have the potential to increase treatment adherence, and because the content is standardized, it can be delivered with greater consistency than face-to-face therapy, lending itself to a clinical research approach. Quit Genius Alcohol (QG-A) is a newly developed comprehensive treatment program for AUD, utilizing a combination of a mobile-app, pharmacotherapy, and breath sensor. The mobile app is informed by the principles of CBT, Motivational Enhancement Therapy (MET), and community reinforcement. QG delivers personalized, behavioral support adjunct to proven pharmacotherapies to individuals who are seeking to reduce their alcohol consumption. An initial pilot investigation of QG-A demonstrated the feasibility of the intervention as well as some promising preliminary outcomes with regards to alcohol use and related psychological variables that are recognized mechanisms of change in CBT treatment for addicted populations. As such, the objective of the proposed investigation is to build on the preliminary outcomes and evaluate the effectiveness of QG-A. This study will compare the efficacy of QG-A, which combines CBT based counseling with pharmacotherapy for alcohol use disorders (naltrexone), delivered via an mobile health app (QG-A), relative to usual care for adults with AUD, which comprises medical management with naltrexone (MM), in reducing alcohol use and associated psychological and functional outcomes.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
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.
OTHER	Medical Management	Participants randomized to receive the MM (Control) intervention will receive monthly appointments with a medical provider and access to naltrexone.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-06-15
• Completion: 2025-07-15
• First posted: 2023-03-01
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States