- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07636447
Alcohol Sensitivity Among Older Adults Who Consume Alcohol
3. juni 2026 opdateret af: University of Florida
Individual Differences in Alcohol Sensitivity
This is a proof-of-concept study exploring individual differences in sensitivity to alcohol among older healthy current drinkers aged 65 to 80. Participants will complete two sessions during which they will complete questionnaires and laboratory measures of mental abilities and brain activity and receive a beverage that may or may not contain a moderate dose of alcohol.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
As a preliminary, proof-of-concept study, the project is designed to provide information regarding variability in response to a moderate dose of alcohol among healthy men and women who are current drinkers and aged 65 to 80.
It is expected that approximately 75 individuals will complete the study.
Participants complete two laboratory sessions.
Each session will include consuming a beverage that may or may not include alcohol.
If the beverage does include alcohol, the volume will not exceed the amount that a drinker might consume in 1 to 2 drinks.
The outcomes will provide information regarding the how older adults vary in their response to alcohol and explore whether alcohol sensitivity is related to selected measures of cognition.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sara Jo Nixon, PhD
- Telefonnummer: 352-294-4920
- E-mail: sjnixon@ufl.edu
Undersøgelse Kontakt Backup
- Navn: Ben Lewis, PhD
- Telefonnummer: 352-294-4920
- E-mail: benlewis@ufl.edu
Studiesteder
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32610
- University of Florida
-
Kontakt:
- Sara Jo Nixon, PhD
- Telefonnummer: 352-294-4920
- E-mail: sjnixon@ufl.edu
-
Kontakt:
- Ben Lewis, PhD
- Telefonnummer: 35222944920
- E-mail: benlewis@ufl.edu
-
Ledende efterforsker:
- Sara Jo Nixon, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria
- Alcohol Drinkers who consume alcohol on a regular basis
- No history of significant substance misuse
- at least 12 years of education or GED equivalence Exclusion Criteria
- current Cigarette smoker
- Type 1 Diabetes or uncontrolled Type 2 Diabetes
- Epilepsy
- Neurodegenerative disorder
- Significant psychiatric disorder such as a psychotic disorder, bipolar disorder, current major depression or PTSD
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Alcohol Condition
Beverage contains an alcohol volume consistent with achieving a sub-intoxicating breath alcohol concentration
|
Described elsewhere
|
|
Placebo komparator: Non-Alcohol Session
Placebo beverage is administered
|
on each of two visits, participants receive either the placebo drink or the drinking containing alcohol
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcohol Effects on Psychomotor Skills as reflected in the Trail Making Test (TMT)
Tidsramme: The placebo and alcohol sessions occur ~ 10-14 days apart.
|
Difference between the number of seconds required to complete the TMT under placebo vs the alcohol condition for each individual
|
The placebo and alcohol sessions occur ~ 10-14 days apart.
|
|
Alcohol Effects on a Working Memory Task requiring Continuous Recognition
Tidsramme: The placebo and alcohol sessions occur ~ 10-14 days apart.
|
Differences in accuracy in identifying previously seen vs. new items a working memory task under alcohol vs placebo conditions for each individual
|
The placebo and alcohol sessions occur ~ 10-14 days apart.
|
|
Alcohol Effects on Neural Activity Measured from Scalp Electroencephalography
Tidsramme: The alcohol and placebo sessions occur ~ 10-14 days apart.
|
Differences in neural activity as reflected obtained through non-invasive electroencephalography under alcohol vs placebo conditions for each individual
|
The alcohol and placebo sessions occur ~ 10-14 days apart.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between alcohol sensitivity and standard cognitive assessment
Tidsramme: The general measure of cognitive abilities is obtained in the first session, prior to the experimental condition. The difference scores are derived by comparing outcomes between alcohol vs placebo sessions which are ~ 10-14 days apart.
|
Correlations between differences under alcohol vs placebo conditions for the psychomotor task, the working memory task, the measure of neural activity and performance on a general measure of cognitive abilities
|
The general measure of cognitive abilities is obtained in the first session, prior to the experimental condition. The difference scores are derived by comparing outcomes between alcohol vs placebo sessions which are ~ 10-14 days apart.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ben Lewis, PhD, University of Florida
- Ledende efterforsker: Sara Jo Nixon, PhD, University of Florida
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. juni 2028
Datoer for studieregistrering
Først indsendt
26. maj 2026
Først indsendt, der opfyldte QC-kriterier
3. juni 2026
Først opslået (Faktiske)
9. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB202600681
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Data will be made available through an NIH repository.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sunde voksne deltagere
-
Al-Azhar UniversityAfsluttetSucces med adult pulpotomi hos patienter med diabetesEgypten
-
Nanjing Medical UniversityRekrutteringAdult Attention Deficit Hyperactivity DisorderKina
-
Wolfson Medical CenterUkendt
-
Ethicon Endo-SurgeryAfsluttetPædiatriske procedurer | Adult Hepato-pancreato-biliær (HPB) procedurer | Voksen nedre gastrointestinale procedurer | Gastriske procedurer for voksne | Gynækologiske procedurer for voksne | Voksen urologiske procedurer | Voksen thoraxprocedurerForenede Stater, Canada, Det Forenede Kongerige
-
Novartis PharmaceuticalsAfsluttetAdult Debut Still's DiseaseJapan
-
AB2 Bio Ltd.AfsluttetStills sygdom, voksendebutTyskland, Frankrig, Schweiz
-
AO GENERIUMAfsluttetStills Sygdom Adult DebutDen Russiske Føderation
-
Rochester Center for Behavioral MedicineShireAfsluttetAdult Attention-Deficit Hyperactivity DisorderForenede Stater
-
Apollo Therapeutics LtdAfsluttetAdult Debut Still's DiseaseForenede Stater, Belgien, Polen, Ukraine
-
Tel-Aviv Sourasky Medical CenterElMindA Ltd; Brainsway; Ornim Medical Ltd.UkendtAdult Attention Deficit DisorderIsrael
Kliniske forsøg med Alcohol (Oral)
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Afsluttet
-
Auburn UniversityIkke rekrutterer endnuAlkohol drikkeForenede Stater
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetLeversygdomme | Alkohol-relaterede lidelserForenede Stater
-
University of Illinois at Urbana-ChampaignCarle Foundation HospitalAfsluttet
-
Sygehus LillebaeltUkendtBakterielle infektioner | Kirurgisk procedure, uspecificeret | Operation sår; InfektionDanmark
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkohol; Brug, problemForenede Stater
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkohol drikke | Problem med at drikkeForenede Stater
-
University of California, RiversideIkke rekrutterer endnuAlkohol; Skadelig brug | AlkoholbrugsforstyrrelseForenede Stater
-
Johnson & Johnson Consumer Inc. (J&JCI)Afsluttet
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Johns Hopkins... og andre samarbejdspartnereAktiv, ikke rekrutterende