Alcohol Sensitivity Among Older Adults Who Consume Alcohol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alcohol (Oral), Placebo Control.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants. Basic parameters: 65 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Individual Differences in Alcohol Sensitivity
Overview
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.
Detailed description
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.
Interventions
- Other Alcohol (Oral)
Described elsewhere - Other Placebo Control
on each of two visits, participants receive either the placebo drink or the drinking containing alcohol
Primary outcome measures
- Alcohol Effects on Psychomotor Skills as reflected in the Trail Making Test (TMT) [Time frame: The placebo and alcohol sessions occur ~ 10-14 days apart.]
- Alcohol Effects on a Working Memory Task requiring Continuous Recognition [Time frame: The placebo and alcohol sessions occur ~ 10-14 days apart.]
- Alcohol Effects on Neural Activity Measured from Scalp Electroencephalography [Time frame: The alcohol and placebo sessions occur ~ 10-14 days apart.]
Secondary outcome measures (1)
- Correlation between alcohol sensitivity and standard cognitive assessment [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT07636447 · IRB202600681