Environment and Alcohol: A Pilot Study

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Mar 5, 2025

Keywords

ClinConnect Summary

The "Environment and Alcohol: A Pilot Study" is a clinical trial aimed at understanding how different activities and environments can affect drinking behaviors and mental health in people with Alcohol Use Disorder (AUD). This study is important because AUD is a serious condition that leads to many health issues and deaths each year. Researchers want to see if engaging in various activities, like using virtual reality or watching videos, can help people with AUD manage their cravings and improve their overall well-being.

To participate, you need to be at least 21 years old and have a diagnosis of AUD. The trial involves up to 10 visits in Baltimore, where you'll have a physical exam and provide information about your drinking habits and mental health. During the study, you'll use an app to answer questions about your daily experiences. You'll also take part in activities that include using a virtual reality system and watching videos, and you'll have the chance to discuss your cravings in a setting that mimics a bar. This study is currently recruiting participants, and it offers an opportunity to contribute to important research that could lead to better treatments for AUD.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• To meet eligibility for this study, participants must meet all the following criteria:
• • 1. At least 21 years old
• • 2. Owns a cellular device ( smart phone ) and is willing to download the EMA application and use it to answer the study questionnaires
• • 3. Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
• • 4. Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \> 7 drinks per week for females or \> 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with \> 3 drinks for females or \> 4 drinks for males during the 28-day period prior to screening
• • 5. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \< 10
• • 6. If a female of childbearing potential: not pregnant or breastfeeding, no intention to become pregnant during the study duration, and agrees to use a highly effective contraception method to prevent pregnancy for the entire study duration. Highly effective contraception methods will be determined by the MAI or designee.
• EXCLUSION CRITERIA:
• Any individual who meets any of the following criteria will be excluded from this study:
• • 1. Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD
• • 2. Medical and/or mental health conditions that are clinically unstable and would therefore compromise the safety and/or scientific integrity of the study, as determined by the MAI or study team respectively.
• • 3. Known history of clinically significant cybersickness.
• • 4. Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant
• • 5. Unable to speak, read, write, and understand English
• • Justification: Many of the assessments have only been validated in English, and therefore, a non-English translation would jeopardize the scientific integrity of the study.