Actively Recruiting

Phase 1
Age: 21Years - 100Years
All Genders
Healthy Volunteers
NCT06860607

Environment and Alcohol: A Pilot Study

Led by National Institute on Drug Abuse (NIDA) · Updated on 2026-05-14

44

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Environment and Alcohol: A Pilot Study

Who Can Participate

Age: 21Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 21 years old
  • Owns a smartphone and willing to download and use the study app
  • Diagnosed with alcohol use disorder based on 2 or more DSM-5 criteria using a valid diagnostic tool
  • Self-reported drinking of more than 7 drinks per week for females or more than 14 drinks per week for males on average during the 28 days before screening, with at least four days exceeding 3 drinks for females or 4 drinks for males
  • Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score less than 10
  • For females of childbearing potential: not pregnant or breastfeeding, no plans to become pregnant during the study, and agrees to use a highly effective contraception method throughout the study
Not Eligible

You will not qualify if you...

  • Current use of FDA-approved medications for alcohol use disorder or seeking treatment for AUD
  • Clinically unstable medical or mental health conditions that compromise safety or study integrity
  • Known history of clinically significant cybersickness
  • Any condition or reason judged by investigators to interfere with participation or safety
  • Unable to speak, read, write, and understand English

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institute on Drug Abuse

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

R

Ryan E Tyler

CONTACT

L

Lorenzo Leggio, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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