Environment and Alcohol: A Pilot Study

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:

• Evaluate the effects of EE on alcohol consumption

Secondary Objectives:

• Evaluate the effects of EE on other ecological momentary assessments (EMA)
• Evaluate the effects of EE on bar-lab assessments

Endpoints:

Primary Endpoints:

• Self-reported alcohol consumed using ecological momentary assessment

Secondary Endpoints:

• State assessments of varying psychological, social, and environmental domains associated with AUD
• - Cue reactivity: AUQ, AAS

• APT
• Alcohol challenge: B-BAES, DEQ-5, AUQ, BrAC

• INCLUSION CRITERIA:

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.

Exclusion criteria

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.