Environment and Alcohol: A Pilot Study (NCT06860607) | Clinical Trial Compass
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
United States44 participantsStarted 2026-07-02
Plain-language summary
Background:
Alcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication. Some people with AUD may also benefit from behavioral and lifestyle changes.
Objective:
To evaluate the effects of different activities and environments on drinking behaviors and mental health in people with AUD.
Eligibility:
People aged 21 years and older with AUD.
Design:
Participants will have up to 10 study visits in Baltimore.
Participants will have a baseline visit. They will have a physical exam with blood and urine tests. They will have a breath test for alcohol and a test that measures body composition. They will answer questions about their alcohol and substance use; mental and physical health; mood and anxiety; and sleep quality.
Participants will download an app called MetricWire. The app will send 3 sets of questions to be answered at different times throughout the day.
The study visits will include 2 stages:
1. Active stage. On these visits, participants will use a virtual reality system called the Meta Quest Pro (MQP) as they choose. Then they may choose among video games, puzzles, books, crafts, and other activities.. These sessions will last for 3 hours.
2. Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours.
On the last visit of each stage, participants will sit in a room that looks like a bar. They will answer questions about their cravings, their urge to drink, and how many drinks they would buy. Participants will be served 1 drink containing alcohol. They will be asked about their cravings and subjective effects of alcohol after drinking it.
Who can participate
Age range
21 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 21 years old
. Owns a cellular device ("smart phone") and is willing to download the EMA application and use it to answer the study questionnaires
. Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
. Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \> 7 drinks per week for females or \> 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with \> 3 drinks for females or \> 4 drinks for males during the 28-day period prior to screening
. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \< 10
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 pilot study on how environment affects alcohol consumption — since it's this early stage, what is actually known so far about the safety and risks of participating, and what unknowns should I be aware of?
2The trial is studying how 'enriched environments' influence alcohol use in people with Alcohol Use Disorder — can you explain what kinds of environmental changes or exposures I might actually experience if I took part in this study?
3Given that this is a pilot study focused on measuring alcohol consumption as an outcome, would I still have access to standard treatment or support for my Alcohol Use Disorder while participating, or could enrollment affect my current care plan?
4Since the trial is still in an early Phase 1 stage, how does the limited data from a pilot study like this compare to what's already known from established treatments for Alcohol Use Disorder, and is standard treatment a better first step for me?
5What would my time commitment look like week to week if I were to discuss enrollment with you, and are there any life or health factors that might make this trial a poor fit for my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If a female of childbearing potential: not pregnant or breastfeeding, no intention to become pregnant during the study duration, and agrees to use a highly effective contraception method to prevent pregnancy for the entire study duration. Highly effective contraception methods will be determined by the MAI or designee.
Exclusion criteria
. Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD
. Medical and/or mental health conditions that are clinically unstable and would therefore compromise the safety and/or scientific integrity of the study, as determined by the MAI or study team respectively.
. Known history of clinically significant cybersickness.
. Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant
. Unable to speak, read, write, and understand English