NCT06860607

Environment and Alcohol: A Pilot Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Description: This study will investigate the effects of cognitive and sensorimotor environmental enrichment (EE) on alcohol drinking, alcohol cue-reactivity, and other related outcomes in participants with alcohol use disorder (AUD). The hypothesis is that the psychological and physiological effects of environmental enrichment will confer therapeutic benefits for people with AUD, especially on measures of alcohol consumption and cue-elicited craving. Objectives: Primary Objectives: 1\. Evaluate the effects of EE on alcohol consumption Secondary Objectives: 1. Evaluate the effects of EE on other ecological momentary assessments (EMA) 2. Evaluate the effects of EE on bar-lab assessments Endpoints: Primary Endpoints: 1\. Self-reported alcohol consumed using ecological momentary assessment Secondary Endpoints: 1. State assessments of varying psychological, social, and environmental domains associated with AUD 2. \- Cue reactivity: AUQ, AAS * APT * Alcohol challenge: B-BAES, DEQ-5, AUQ, BrAC

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-22
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2025-03-06
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States