Environment and Alcohol: A Pilot Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT06860607
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption — BEHAVIORAL
    This study investigates how different environments and activities affect alcohol consumption and related outcomes.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Subject with alcohol use disorder
    subjects (Female/ Male) aged 21 and up

Primary Outcome Measure

Evaluate the effects of EE on alcohol consumption [ Time Frame: 1-3 months for each participant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute on Drug AbuseBaltimoreMaryland21224
Lorenzo Leggio, M.D.
240-478-1503

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