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App-Based treatment shows promise for alcohol addiction

NCT ID NCT05748639

Disease control Sponsor: Quit Genius Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested a digital health app (QG-A) that combines cognitive-behavioral therapy with the medication naltrexone to help adults with moderate to severe alcohol use disorder reduce their drinking. 242 participants were randomly assigned to either the app-based program or standard medical care. The study aimed to see if the digital approach was more effective at cutting alcohol use and improving mental health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone
What this could lead to
If successful, this could provide an effective, scalable digital treatment option for alcohol use disorder that combines medication and therapy.
What could go wrong
The trial is completed but results are not yet widely reported. The digital approach may not work for everyone, and participants must be willing to take naltrexone, which can have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

242 people

The number who actually took part.

Started

Jan 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 or older; * A US resident; * Using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher); * Diagnostic and Statistical Manual-V diagnosis of either a moderate or severe Alcohol Use Disorder; * Currently has health insurance; * Able to provide informed consent; * Currently employed; * Willing and able to participate in study procedures; * Willing to take naltrexone; and * Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participants should be under the care of a physician or other qualified healthcare provider with whom the participant provides documented permission to coordinate care with the QG-A care team. Exclusion Criteria: * Known sensitivity to naltrexone; * Pregnant, breast feeding, or unwilling to use contraceptive methods; * Presence of serious medical or psychiatric disorders that would, in the opinion of the medical provider, make participation hazardous or regular follow-up unlikely (e.g., suicidal ideation, acute hepatitis, unstable cardiovascular, liver or renal disease); * A current pattern of alcohol or sedative use, as assessed by the QG-A licensed medical provider, which would preclude safe participation in the study and/or would likely require imminent medical detoxification; * Having used acamprosate, disulfiram, or naltrexone, within the past 30 days prior to screening; * Takes an opioid medication on a routine basis for a pain condition or has anticipated/planned surgery that will require opioid maintenance during the study timeframe; * Has undergone more than one inpatient medical detoxification treatment; and * Lack of proficiency in English.

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Conditions

The condition(s) this trial relates to.

alcohol abuse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder

Contacts and locations

Locations

  • Quit Genius

    New York, New York, 10001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.