What side effects are associated with this type of intervention?

Common treatments for alcoholism include pharmacotherapy and psychosocial interventions. Pharmacological treatments such as naltrexone, acamprosate, and disulfiram can cause side effects like nausea, headache, dizziness, and in the case of disulfiram, severe reactions if alcohol is consumed. Psychosocial interventions, including cognitive-behavioral therapy (CBT) and digital therapeutic interventions like Quit Genius, generally have fewer physical side effects but may cause emotional discomfort as patients confront their behaviors and thoughts. Digital interventions may also lead to issues related to technology use, such as screen fatigue or frustration with the digital platform.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcohol use disorder, including disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, naltrexone reduces the euphoric effects and cravings for alcohol, and acamprosate helps maintain abstinence by stabilizing brain chemistry. While digital therapeutic interventions like Quit Genius are being studied, they are not yet FDA-approved specifically for alcohol use disorder. These digital interventions typically combine behavioral therapy with digital tools to support treatment adherence and reduce alcohol consumption.

What other types of research exist?

Promising alternatives to Quit Genius for alcoholism treatment include: 1) NoFumo+, a cognitive behavioral therapy-based app initially designed for smoking cessation but potentially adaptable for alcohol use disorder. 2) Tweet2Quit, a social network intervention that could be adapted for alcohol use, leveraging peer support through daily automated communications. 3) Smoke Free app with a supportive chatbot, which could be modified to support alcohol cessation by enhancing user engagement and providing real-time support.

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Digital Intervention for Alcoholism (Alcohol RCT Trial)

Phase 3

Recruiting

Research Sponsored by Quit Genius

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6-months post-treatment entry

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests QG-A, a mobile app-based treatment for adults with alcohol problems. It combines therapy, medication, and a breath sensor to help reduce drinking. The goal is to see if QG-A is more effective than other treatments.

Who is the study for?

This trial is for US residents over 18 with moderate to severe Alcohol Use Disorder who own a compatible smartphone, have health insurance, are currently employed, and can consent to the study. They must be willing to take naltrexone and not require immediate detoxification or have used certain alcoholism treatments recently.

What is being tested?

The study compares Quit Genius (QG-A), a digital intervention app for alcohol use disorder, against typical care including medication management. It aims to see if QG-A better reduces alcohol consumption and improves mental health and functionality over six months.

What are the potential side effects?

Potential side effects may include those associated with naltrexone such as nausea, headache, dizziness, fatigue or sleep disorders. The mobile application itself is not expected to cause direct physical side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6-months post-treatment entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6-months post-treatment entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6-months post-treatment entry for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol use

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Quit Genius - AlcoholExperimental Treatment1 Intervention

QG-A is a smart phone application targeting alcohol use disorder. QG-A includes standardized cognitive-behavioral therapy in the form of videos, in-app text, audio recordings, and quizzes. The application provides users with information on how to reduce or abstain from alcohol use. Once successfully enrolled in QG-A, a medical provider will evaluate each QG-A participant for appropriateness for pharmacotherapy during an initial 60-minute assessment to confirm an alcohol use disorder diagnosis and collect relevant medical and psychiatric history of the patient. The medical provider will subsequently prescribe oral naltrexone via the QG-A telemedicine platform. A study counselor will provide manualized CBT-based support to QG-A participants via the video telemedicine function, as well as asynchronously via the in-app chat function.

Group II: Medical ManagementActive Control1 Intervention

Medical management comprises standard care for alcohol use disorder. A medical provider, upon evaluation of each participant for appropriateness for pharmacotherapy, will subsequently prescribe naltrexone via a non-QG-A telemedicine platform, according to standard clinical practice. Participants will meet with the medical provider monthly over the 6-month course of treatment. In MM, participants receive dose adjustments and brief medical management as normally provided to patients in office-based settings (session duration is 15-20 minutes). The medical provider will deliver education about the study medication and answer any participant questions. Subsequent 15-20 minute sessions will review drinking patterns, overall functioning, medication adherence, and adverse effects. Participants who discontinue medication because of intolerance can continue to attend monthly medical management sessions to support abstinence.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism include pharmacotherapy and behavioral interventions. Pharmacotherapy often involves medications like naltrexone, which blocks opioid receptors to reduce cravings and the rewarding effects of alcohol, and acamprosate, which stabilizes chemical signaling in the brain to reduce withdrawal symptoms. Behavioral interventions, such as Cognitive Behavioral Therapy (CBT), focus on changing drinking behaviors and thought patterns. Digital therapeutic interventions like Quit Genius combine these approaches by providing structured, accessible support through digital platforms, enhancing adherence and engagement. These mechanisms are crucial for alcoholism patients as they address both the physiological and psychological aspects of addiction, increasing the likelihood of sustained recovery.

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