Effects of environment on drinking behaviors in people with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate how different activities and environments influence drinking behaviors and mental health in individuals with alcohol use disorder (AUD). Participants aged 21 and older will undergo a series of assessments, including physical exams, blood and urine tests, and psychological evaluations. They will also use an app to provide real-time feedback on their alcohol consumption and related behaviors. The study will focus on the impact of environmental enrichment on reducing alcohol consumption and cravings.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institute on Drug Abuse
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Lorenzo Leggio, M.D. — National Institute on Drug Abuse (NIDA)
• Study coordinator: Ryan E Tyler
• Email: ryan.tyler@nih.gov
• Phone: (240) 789-0347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.