Environment and Alcohol: A Pilot Study

Phase 1

Recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT06860607
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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, AUQ, BrAC

Study Timeline

• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-06
• Status Verified: 2025-05-16
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-05-26
• Primary Completion: 2027-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the effects of EE on alcohol consumption	1-3 months for each participant	Self-reported alcohol consumed using ecological momentary assessment

Secondary Outcome Measures

Name	Time	Method
Evaluate the effects of EE on other EMA assessments	1-3 months for each participant	Real-time, real-world data collection of state variables and alcohol consumption enhances the ecological validity of the data. This also allows for evaluation of how dynamics in psychological, social and environmental measures are related to changes in alcohol consumption.
Evaluate the effects of EE on bar-lab assessments	1-3 months for each participant	Alcohol craving (measure here via AUQ) is a key factor and predictor of persistent and heavy alcohol use and is attenuated by some treatments. AAS measures attention to alcohol cues. APT serves as a measure of economic demand for alcohol. The subjective response to alcohol is a predictor of AUD vulnerability and treatment outcomes.

Trial Locations

Locations (1)

National Institute on Drug Abuse; 🇺🇸 Baltimore, Maryland, United States