Integrated Digital Intervention for Alcohol Use Disorder

NCT05748639 | Completed Phase 2

• 1 other identifier: QG01
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol use

  Change in past 30-day alcohol use

  Baseline to 6-months post-treatment entry

Study Arms (2)

Quit Genius - Alcohol

EXPERIMENTAL

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.

Other: Mobile health application

Medical Management

ACTIVE COMPARATOR

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.

Other: Medical Management

Interventions

Mobile health application OTHER

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.

Also known as: QG-A

Quit Genius - Alcohol

Medical Management OTHER

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

Also known as: TAU

Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quit Genius: lead

Study Sites (1)

Quit Genius

New York, New York, 10001, United States

Location

Related Publications (7)

• Bandawar M, Narasimha VL, Chand P. Use of digital technology in addiction disorders. Indian J Psychiatry. 2018 Feb;60(Suppl 4):S534-S540. doi: 10.4103/psychiatry.IndianJPsychiatry_21_18.

  PMID: 29540927 RESULT

• Singh K, Drouin K, Newmark LP, Lee J, Faxvaag A, Rozenblum R, Pabo EA, Landman A, Klinger E, Bates DW. Many Mobile Health Apps Target High-Need, High-Cost Populations, But Gaps Remain. Health Aff (Millwood). 2016 Dec 1;35(12):2310-2318. doi: 10.1377/hlthaff.2016.0578.

  PMID: 27920321 RESULT

• Messner E-M, Probst T, O'Rourke T, Stoyanov S, Baumeister H. mHealth Applications: Potentials, Limitations, Current Quality and Future Directions. In: Baumeister H, Montag C, eds. Digital Phenotyping and Mobile Sensing: New Developments in Psychoinformatics. Studies in Neuroscience, Psychology and Behavioral Economics. Springer International Publishing; 2019:235-248. doi:10.1007/978-3-030-31620-4_15

  RESULT

• Kranzler HR, Stephenson JJ, Montejano L, Wang S, Gastfriend DR. Persistence with oral naltrexone for alcohol treatment: implications for health-care utilization. Addiction. 2008 Nov;103(11):1801-8. doi: 10.1111/j.1360-0443.2008.02345.x.

  PMID: 19032530 RESULT

• Hammarlund R, Crapanzano KA, Luce L, Mulligan L, Ward KM. Review of the effects of self-stigma and perceived social stigma on the treatment-seeking decisions of individuals with drug- and alcohol-use disorders. Subst Abuse Rehabil. 2018 Nov 23;9:115-136. doi: 10.2147/SAR.S183256. eCollection 2018.

  PMID: 30538599 RESULT

• Srisurapanont M, Jarusuraisin N. Naltrexone for the treatment of alcoholism: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2005 Jun;8(2):267-80. doi: 10.1017/S1461145704004997.

  PMID: 15850502 RESULT

• Miller PM, Book SW, Stewart SH. Medical treatment of alcohol dependence: a systematic review. Int J Psychiatry Med. 2011;42(3):227-66. doi: 10.2190/PM.42.3.b.

  PMID: 22439295 RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is designed as a 2-arm, parallel-group, randomized controlled trial with 12-, 24-, 36-, and 52-week follow-up, to evaluate the effect of the treatment group (QG-A) versus a control group (MM) on alcohol use outcomes.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 1, 2023
• Study Start: January 1, 2023
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)