NCT05611502

Brief Summary

The purpose of this study is to help understand how attention processes influence brain engagement during emotion and social cognition. The investigators also want to know if these processes are associated with drinking alcohol. Participation includes three study visits of about 2 hours each over approximately a month. The first visit involves a magnetic resonance imaging (MRI) scan and answering survey questions. Each of the next two visits will involve a session of transcranial magnetic stimulation (TMS, a non-invasive brain stimulation technique) followed by another MRI scan. People in the Auburn/Opelika area 19 or older are eligible to participate. People who drink alcohol and people who do not drink or don't drink very much are invited to participate.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

October 26, 2022

Last Update Submit

October 2, 2025

Conditions

Keywords

alcoholattentionTMSbinge drinkingemotionsocial cognitionmoralMRIfrontal eye fieldsmoral cognition

Outcome Measures

Primary Outcomes (3)

  • Change in attention switching

    MRI Task- analysis of behavioral data

    Baseline, immediately following TMS A, immediately following TMS B

  • Change in sociomoral attention switching

    MRI Task- analysis of behavioral data

    Baseline, immediately following TMS A, immediately following TMS B

  • Change in cue reactivity

    MRI Task- analysis of behavioral data

    Baseline, immediately following TMS A, immediately following TMS B

Secondary Outcomes (3)

  • Change in brain activity attention switching

    Baseline, immediately following TMS A, immediately following TMS B

  • Change in brain activity during sociomoral attention switching

    Baseline, immediately following TMS A, immediately following TMS B

  • Change in brain activity during cue reactivity

    Baseline, immediately following TMS A, immediately following TMS B

Study Arms (2)

TMS A

EXPERIMENTAL

TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI

Device: TMS

TMS B

ACTIVE COMPARATOR

TMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI

Device: TMS

Interventions

TMSDEVICE

TMS will be administered in a pattern that is either excitatory or inhibitory.

Also known as: Magventure MagPro
TMS ATMS B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age 18 or Older
  • A. (Drinker Group): Reports consuming 4 \[if female\]/ 5 \[if male\] or more standard drinks on one occasion at least 2 times a month AND/OR reports consuming more than 7 \[if female\]/ 14 \[if male\] standard drinks per week on average
  • B. (Healthy Volunteer Group): Reports consuming 4 \[if female\]/ 5 \[if male\] or more standard drinks on one occasion less than once a month AND reports consuming less than 7 \[if female\]/ 14 \[if male\] standard drinks per week on average

You may not qualify if:

  • MRI Contraindications
  • Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
  • Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
  • Hearing loss, including tinnitus, that might be made worse by MRI or TMS
  • TMS Contraindications
  • Has ever had a seizure, or has a family history of epilepsy
  • Taking medications or substances that lower the seizure threshold\*
  • Implanted devices that are in the head or rely on physiological signals
  • History of neurological disease, such as stroke or brain tumor
  • Head injury with loss of consciousness greater than 30 minutes
  • Actively withdrawing from alcohol
  • Family history of schizophrenia or presence of psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingBinge Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Samantha J Fede, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 10, 2022

Study Start

August 11, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Data will be shared through the NIAAA Data Archive according to standard NIAAA procedures. This will include deidentified behavioral, self-report, and imaging data. Participants will have the option to opt out of having their individual data available.

Shared Documents
STUDY PROTOCOL, ICF

Locations