- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06885190
Multisensorní zpracování alkoholových podnětů u pijáků mladých dospělých
Binge drinking is common among young adults and is related to many negative health outcomes including blackouts, risky sex, drunk driving, alcohol use disorder, and liver disease. Understanding whether there are differences in how binge drinkers respond to alcohol-related cues and whether this is related to craving is important for improving interventions and treatments. The proposed study will compare behavioral and neural processing of alcohol and non-alcohol cues in a single sensory modality (vision) with that of cues presented in multiple sensory modalities (vision, touch, and smell) with varying degrees of realistic appearance (images, virtual reality, real objects). Participants will answer questionnaires related to their physical and mental health and recent alcohol and drug use. Those eligible for the study will complete two in-person lab sessions. During both sessions they will be asked to view a series of cues which will include images on a computer screen, objects presented in virtual reality, or real objects. Sometimes these will be presented just visually and other times they will be combined with the presentation of specific smells or an object to touch. Some of these cues will be alcohol-related and others will be neutral (non-alcohol-related). Brainwave activity, as measured by the electroencephalogram (EEG), and reports of alcohol craving will be collected during these sessions. It is expected that brainwave activity will be greatest in response to multisensory cues compared to that in response unisensory (visual only) cues. It is also expected that young adults with a recent history of binge drinking will show the greatest brainwave activity in response to multisensory alcohol cues compared to social drinkers. Binge drinkers will also report more alcohol craving in response to multisensory alcohol cues compared to social drinkers. It is anticipated that brainwave responses will increase as the level of realism of the cues increases. Binge drinkers will also show stronger brainwave and craving responses to multisensory alcohol cues presented as real objects. Finally, binge drinkers will show lessened brain and craving responses when multisensory cues do not match compared to social drinkers. For example, if a photo shows an alcoholic drink but the smell presented is not alcohol related, binge drinkers will show less attentive brain activity toward those mismatched cues. Given that most alcohol cues in daily life are experienced across multiple senses simultaneously, results of this research will provide a better understanding of the relation between alcohol cue processing and craving, and will inform development of more effective programs for decreasing young adult risky drinking behavior.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Rebecca J Houston, PhD
- Telefonní číslo: 585-475-5205
- E-mail: rjhgss@rit.edu
Studijní záloha kontaktů
- Jméno: Elena Fedorovskaya, PhD
- Telefonní číslo: 585-475-6952
- E-mail: eafppr@rit.edu
Studijní místa
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New York
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Rochester, New York, Spojené státy, 14623
- Nábor
- Rochester Institute of Technology
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Kontakt:
- Rebecca J Houston, PhD
- Telefonní číslo: 585-475-5205
- E-mail: rjhgss@rit.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- ages 18 to 25 years old
- meet criteria for either the binge drinker or social drinker groups previously described
Exclusion Criteria:
- history of head injury involving loss of consciousness of 10+ minutes
- colorblindness
- hearing, tactile, olfactory or uncorrected vision deficits
- history of seizures
- neurological disorder diagnosis
- mental health history of psychosis or mania
- history of alcohol or substance use disorder diagnosis
- illicit drug use in the past 30 days
- changes to psychotropic medication type or dose in past 3 months
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Young Adult Binge Drinkers
Participants ages 18 to 25 with a history of binge drinking (at least 2 episodes of 5+ standard drinks per episode for males/4+ standard drinks per episode for females) in the past month and at least 4+/3+ (males/females) score on the Alcohol Use Disorder Identification Test. |
Participants will complete two tasks in which they will be presented with unisensory visual and multisensory stimuli combining visual, olfactory, and/or tactile sensory modalities. Stimulus content will be either alcohol-related or neutral (non-alcohol-related). Additionally in the Passive Viewing Task, stimuli will vary on the degree of visual realism. Specifically, participants will be presented with two-dimensional images, three-dimensional virtual reality simulations, and real physical objects. In the second task, a Cross-modal Stroop-like task, participants will be asked to press a button to indicate whether the presented stimuli match in terms of the content presented in each sensory modality. Electroencephalographic (EEG) brain activity, eye movements, responses, and self-reported craving will be collected while participants complete the tasks. |
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Aktivní komparátor: Young Adult Social Drinkers
Participants ages 18 to 25 who report drinking alcohol at least once in the past month but no current history of a binge pattern (i.e., 2 or fewer drinks per episode) AND score less than 4/3 (males/females) on the Alcohol Use Disorder Identification Test. |
Participants will complete two tasks in which they will be presented with unisensory visual and multisensory stimuli combining visual, olfactory, and/or tactile sensory modalities. Stimulus content will be either alcohol-related or neutral (non-alcohol-related). Additionally in the Passive Viewing Task, stimuli will vary on the degree of visual realism. Specifically, participants will be presented with two-dimensional images, three-dimensional virtual reality simulations, and real physical objects. In the second task, a Cross-modal Stroop-like task, participants will be asked to press a button to indicate whether the presented stimuli match in terms of the content presented in each sensory modality. Electroencephalographic (EEG) brain activity, eye movements, responses, and self-reported craving will be collected while participants complete the tasks. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Event-related Potential Amplitudes in Response to Alcohol and Neutral Cues
Časové okno: Baseline and follow-up (within 1 week)
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Amplitude (magnitude) of electrocortical activity assessed in response to alcohol-related and neutral cues presented either visually or in visual-olfactory or visual-tactile combinations. |
Baseline and follow-up (within 1 week)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Rebecca J Houston, PhD, Rochester Institute of Technology
Publikace a užitečné odkazy
Obecné publikace
- Hone-Blanchet A, Wensing T, Fecteau S. The use of virtual reality in craving assessment and cue-exposure therapy in substance use disorders. Front Hum Neurosci. 2014 Oct 17;8:844. doi: 10.3389/fnhum.2014.00844. eCollection 2014.
- Hill-Bowen LD, Riedel MC, Poudel R, Salo T, Flannery JS, Camilleri JA, Eickhoff SB, Laird AR, Sutherland MT. The cue-reactivity paradigm: An ensemble of networks driving attention and cognition when viewing drug and natural reward-related stimuli. Neurosci Biobehav Rev. 2021 Nov;130:201-213. doi: 10.1016/j.neubiorev.2021.08.010. Epub 2021 Aug 13.
- Connor JP, Kavanagh DJ, Andrade J, May J, Feeney GF, Gullo MJ, White AM, Fry ML, Drennan J, Previte J, Tjondronegoro D. Alcohol consumption in young adults: the role of multisensory imagery. Addict Behav. 2014 Mar;39(3):721-4. doi: 10.1016/j.addbeh.2013.11.023. Epub 2013 Dec 4.
- Kiyak C, Simonetti ME, Norton S, Deluca P. The efficacy of cue exposure therapy on alcohol use disorders: A quantitative meta-analysis and systematic review. Addict Behav. 2023 Apr;139:107578. doi: 10.1016/j.addbeh.2022.107578. Epub 2022 Dec 12.
- Mellentin AI, Skot L, Nielsen B, Schippers GM, Nielsen AS, Stenager E, Juhl C. Cue exposure therapy for the treatment of alcohol use disorders: A meta-analytic review. Clin Psychol Rev. 2017 Nov;57:195-207. doi: 10.1016/j.cpr.2017.07.006. Epub 2017 Jul 27.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SRS00020124
- R15AA031579-01A1 (Grant/smlouva NIH USA)
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Plánujete sdílet data jednotlivých účastníků (IPD)?
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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