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| ID | Type | Description | Link |
|---|---|---|---|
| 002341-DA |
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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:
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.
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:
Endpoints:
Primary Endpoints:
1. 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject with alcohol use disorder | Other | subjects (Female/ Male) aged 21 and up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption | Behavioral | This study investigates how different environments and activities affect alcohol consumption and related outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effects of EE on alcohol consumption | Self-reported alcohol consumed using ecological momentary assessment | 1-3 months for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effects of EE on other EMA assessments | 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. | 1-3 months for each participant |
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To meet eligibility for this study, participants must meet all the following criteria:
EXCLUSION CRITERIA:
Any individual who meets any of the following criteria will be excluded from this study:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan E Tyler | Contact | (240) 789-0347 | ryan.tyler@nih.gov | |
| Lorenzo Leggio, M.D. | Contact | (240) 478-1503 | lorenzo.leggio@nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Leggio, M.D. | National Institute on Drug Abuse (NIDA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute on Drug Abuse | Recruiting | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27475769 | Background | 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. | |
| 36089933 | Background | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D004467 | Economics |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004472 | Health Care Economics and Organizations |
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| Evaluate the effects of EE on bar-lab assessments | 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. | 1-3 months for each participant |
| 16924259 | Background | 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. |
| 21524263 | Background | 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. |