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Environment and Alcohol: A Pilot Study

NCT06860607 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption

This study investigates how different environments and activities affect alcohol consumption and related outcomes.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Lorenzo Leggio, M.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2027-03-01
Completion
2028-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860607 on ClinicalTrials.gov