NCT06860607

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. 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. 2.Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
23mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 21, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 16, 2026

Status Verified

April 2, 2026

Enrollment Period

10 months

First QC Date

March 5, 2025

Last Update Submit

April 15, 2026

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effects of EE on alcohol consumption

    Self-reported alcohol consumed using ecological momentary assessment

    1-3 months for each participant

Secondary Outcomes (2)

  • Evaluate the effects of EE on other EMA assessments

    1-3 months for each participant

  • Evaluate the effects of EE on bar-lab assessments

    1-3 months for each participant

Study Arms (1)

Subject with alcohol use disorder

OTHER

subjects (Female/ Male) aged 21 and up

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

Interventions

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

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

Subject with alcohol use disorder

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To meet eligibility for this study, participants must meet all the following criteria:
  • At least 21 years old
  • Owns a cellular device ("smart phone") and is willing to download the EMA application and use it to answer the study questionnaires
  • 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))
  • 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
  • Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \< 10
  • 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.

You may not qualify if:

  • Any individual who meets any of the following criteria will be excluded from this study:
  • 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
  • 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.
  • Known history of clinically significant cybersickness.
  • Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (4)

  • Koob GF, Volkow ND. Neurobiology of addiction: a neurocircuitry analysis. Lancet Psychiatry. 2016 Aug;3(8):760-773. doi: 10.1016/S2215-0366(16)00104-8.

    PMID: 27475769BACKGROUND

  • Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022.

    PMID: 36089933BACKGROUND

  • Nithianantharajah J, Hannan AJ. Enriched environments, experience-dependent plasticity and disorders of the nervous system. Nat Rev Neurosci. 2006 Sep;7(9):697-709. doi: 10.1038/nrn1970.

    PMID: 16924259BACKGROUND

  • Edwards S, Kenna GA, Swift RM, Leggio L. Current and promising pharmacotherapies, and novel research target areas in the treatment of alcohol dependence: a review. Curr Pharm Des. 2011;17(14):1323-32. doi: 10.2174/138161211796150765.

    PMID: 21524263BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

EthanolEconomics

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHealth Care Economics and Organizations

Study Officials

  • Lorenzo Leggio, M.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan E Tyler

CONTACT

(240) 789-0347ryan.tyler@nih.gov

Lorenzo Leggio, M.D.

CONTACT

(240) 478-1503lorenzo.leggio@nih.gov

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 6, 2025

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 16, 2026

Record last verified: 2026-04-02

Locations

US(1)