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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
Alcohol RCT Trial Summary
This trial will compare two methods of treating alcohol use disorder to determine which is more effective and cost-effective.
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.Check my eligibility
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.See study design
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.
Alcohol RCT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol use
Alcohol RCT 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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Who is running the clinical trial?
Quit GeniusLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used acamprosate, disulfiram, or naltrexone in the last 30 days.I regularly take opioid medication for pain or will need it for upcoming surgery.I am 18 years old or older.I am willing to take naltrexone.
Research Study Groups:
This trial has the following groups:- Group 1: Quit Genius - Alcohol
- Group 2: Medical Management
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being sought for this clinical trial?
"Per the data posted on clinicaltrials.gov, this project is actively accepting participants at present. It was initially published on January 1st 2023 and underwent its most recent update on February 17th of that same year."
Answered by AI
How many individuals are involved in this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this medical trial, which was initially published on January 1st 2023, is currently accepting participants. Roughly 300 individuals must be enlisted from a single site."
Answered by AI
Has Quit Genius - Alcohol attained FDA authorization?
"Our team at Power assigned Quit Genius - Alcohol a rating of 3, due to the abundant evidence underpinning its efficacy and safety from Phase 3 clinical trials."
Answered by AI
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