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RecruitingNCT07636447Updated Sep 30, 2026

Alcohol Sensitivity Among Older Adults Who Consume Alcohol

An interventional study of Alcohol (Oral) and Placebo Control in Healthy Adult Participants, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
65 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy Adult Participants

Keywords

  • Older adults, alcohol drinkers, cognition
03

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Alcohol Condition

    Beverage contains an alcohol volume consistent with achieving a sub-intoxicating breath alcohol concentration

    Other: Alcohol (Oral)

  • Placebo comparator
    Non-Alcohol Session

    Placebo beverage is administered

    Other: Placebo Control

Interventions

  • OtherAlcohol (Oral)

    Described elsewhere

  • OtherPlacebo Control

    on each of two visits, participants receive either the placebo drink or the drinking containing alcohol

05

What researchers measure

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.

06

Study locations

1 of 1 sites recruiting
  • University of Florida
    Gainesville, Florida 32610, United States
    • Sara Jo Nixon, PhD · Contact · sjnixon@ufl.edu · 352-294-4920
    • Ben Lewis, PhD · Contact · benlewis@ufl.edu · 35222944920
    • Sara Jo Nixon, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Data will be made available through an NIH repository.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07636447
Lead sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Oct 3, 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Sara Jo Nixon, PhD
Contact
sjnixon@ufl.edu
352-294-4920
Ben Lewis, PhD
Contact
benlewis@ufl.edu
352-294-4920
Sara Jo Nixon, PhD
principal investigator · University of Florida
Ben Lewis, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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