Alcohol Sensitivity Among Older Adults Who Consume Alcohol
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Alcohol Drinkers who consume alcohol on a regular basis
No history of significant substance misuse
at least 12 years of education or GED equivalence
Disqualifiers
current Cigarette smoker
Type 1 Diabetes or uncontrolled Type 2 Diabetes
Epilepsy
Neurodegenerative disorder
Trial design
Design model
Single group
Treatments tested in this trial
Alcohol (Oral)
Other interventionDescribed elsewhere
Placebo Control
Other interventionon each of two visits, participants receive either the placebo drink or the drinking containing alcohol
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Alcohol ConditionExperimental treatment 1 intervention
Group B: Non-Alcohol SessionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Alcohol Effects on Psychomotor Skills as reflected in the Trail Making Test (TMT)
Difference between the number of seconds required to complete the TMT under placebo vs the alcohol condition for each individual
Time frame
The placebo and alcohol sessions occur ~ 10-14 days apart.2
Alcohol Effects on a Working Memory Task requiring Continuous Recognition
Differences in accuracy in identifying previously seen vs. new items a working memory task under alcohol vs placebo conditions for each individual
Time frame
The placebo and alcohol sessions occur ~ 10-14 days apart.3
Alcohol Effects on Neural Activity Measured from Scalp Electroencephalography
Differences in neural activity as reflected obtained through non-invasive electroencephalography under alcohol vs placebo conditions for each individual
Time frame
The alcohol and placebo sessions occur ~ 10-14 days apart.Secondary outcomes
1
Correlation between alcohol sensitivity and standard cognitive assessment
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
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov