Healthy Adult ParticipantsNCT07636447
Alcohol Sensitivity Among Older Adults Who Consume Alcohol
A study testing Alcohol (Oral) in people with Healthy Adult Participants, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Alcohol (Oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Sara Jo Nixon, PhD, 352-294-4920, sjnixon@ufl.edu
Ben Lewis, PhD, 35222944920, benlewis@ufl.edu
About this study
Official title: 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.
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.
- Conditions
- Healthy Adult Participants
- Being tested
- Alcohol (Oral), Placebo Control
- Keywords
- Older adults, alcohol drinkers, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol (Oral)Other
Described elsewhere
Placebo ControlOther
on each of two visits, participants receive either the placebo drink or the drinking containing alcohol
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Condition | Experimental | Beverage contains an alcohol volume consistent with achieving a sub-intoxicating breath alcohol concentration Receives: Other: Alcohol (Oral) |
| Non-Alcohol Session | Placebo comparator | Placebo beverage is administered Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start3 Oct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sara Jo Nixon, PhD, Principal investigator, University of FloridaBen Lewis, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636447
- Sponsor's protocol ID
- IRB202600681
- Other IDs
- 1R21AA032614-01A1
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available through an NIH repository.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in Alcohol Sensitivity
- ClinicalTrials.gov ID
- NCT07636447
- Acronym / sponsor ID
- IRB202600681
- Conditions
- Healthy Adult Participants
- Keywords
- Older adults, alcohol drinkers, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 3 Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Condition | Experimental | Other: Alcohol (Oral)Beverage contains an alcohol volume consistent with achieving a sub-intoxicating breath alcohol concentration |
| Non-Alcohol Session | Placebo comparator | Other: Placebo ControlPlacebo beverage is administered |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol (Oral)Described elsewhere | Other | Alcohol Condition |
| Placebo Controlon each of two visits, participants receive either the placebo drink or the drinking containing alcohol | Other | Non-Alcohol Session |
Primary outcome
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.
Difference between the number of seconds required to complete the TMT under placebo vs the alcohol condition for each individual
Alcohol Effects on a Working Memory Task requiring Continuous Recognition
Time frame: 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
Alcohol Effects on Neural Activity Measured from Scalp Electroencephalography
Time frame: 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
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Data will be made available through an NIH repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Jo Nixon, PhD principal investigator
University of Florida
Ben Lewis, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol (Oral) in people with Healthy Adult Participants, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Jo Nixon, PhD (352-294-4920, sjnixon@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.