Medio ambiente y alcohol: un estudio piloto
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:
- 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.
- Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
- Evaluate the effects of EE on other ecological momentary assessments (EMA)
- Evaluate the effects of EE on bar-lab assessments
Endpoints:
Primary Endpoints:
1. Self-reported alcohol consumed using ecological momentary assessment
Secondary Endpoints:
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State assessments of varying psychological, social, and environmental domains associated with AUD
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- Cue reactivity: AUQ, AAS
- APT
- Alcohol challenge: B-BAES, DEQ-5, AUQ, BrAC
Pupil diameter
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ryan E Tyler
- Número de teléfono: (240) 789-0347
- Correo electrónico: ryan.tyler@nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Lorenzo Leggio, M.D.
- Número de teléfono: (667) 312-5188
- Correo electrónico: lorenzo.leggio@nih.gov
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Reclutamiento
- National Institute on Drug Abuse
-
Contacto:
- Lorenzo Leggio, M.D.
- Número de teléfono: 240-478-1503
- Correo electrónico: lorenzo.leggio@nih.gov
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Subject with alcohol use disorder
subjects (Female/ Male) aged 21 and up |
This study investigates how different environments and activities affect alcohol consumption and related outcomes. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate the effects of EE on alcohol consumption
Periodo de tiempo: 1-3 months for each participant
|
Self-reported alcohol consumed using ecological momentary assessment |
1-3 months for each participant
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate the effects of EE on other EMA assessments
Periodo de tiempo: 1-3 months for each participant
|
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
|
|
Evaluate the effects of EE on bar-lab assessments
Periodo de tiempo: 1-3 months for each participant
|
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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lorenzo Leggio, M.D., National Institute on Drug Abuse (NIDA)
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10002341
- 002341-DA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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