Alcohol Sensitivity Among Older Adults Who Consume Alcohol

NCT07636447 | Not Yet Recruiting

• 1 other identifier: IRB202600681
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Participants

Keywords

Older adults, alcohol drinkers, cognition

Outcome Measures

Primary Outcomes (3)

• 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

  The placebo and alcohol sessions occur ~ 10-14 days apart.

• 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

  The placebo and alcohol sessions occur ~ 10-14 days apart.

• 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

  The alcohol and placebo sessions occur ~ 10-14 days apart.

Secondary Outcomes (1)

• Correlation between alcohol sensitivity and standard cognitive assessment

  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.

Study Arms (2)

Alcohol Condition

EXPERIMENTAL

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

Other: Alcohol (Oral)

Non-Alcohol Session

PLACEBO COMPARATOR

Placebo beverage is administered

Other: Placebo Control

Interventions

Placebo Control OTHER

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

Non-Alcohol Session

Alcohol (Oral) OTHER

Described elsewhere

Alcohol Condition

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Alcohol Drinkers who consume alcohol on a regular basis
• No history of significant substance misuse

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Sara Jo Nixon, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ben Lewis, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Jo Nixon, PhD

CONTACT

352-294-4920; sjnixon@ufl.edu

Ben Lewis, PhD

CONTACT

352-294-4920; benlewis@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)