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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05611502
Other study ID # 21510
Secondary ID R00AA027830
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2022
Est. completion date December 15, 2024

Study information

Verified date December 2023
Source Auburn University
Contact SCAMPI Lab
Phone 334-521-2807
Email scampi@auburn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 or Older 2A. (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 2B. (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 Exclusion Criteria: 1. MRI Contraindications 1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos) 2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr 3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS 2. TMS Contraindications 1. Has ever had a seizure, or has a family history of epilepsy 2. Taking medications or substances that lower the seizure threshold* 3. Implanted devices that are in the head or rely on physiological signals 4. History of neurological disease, such as stroke or brain tumor 5. Head injury with loss of consciousness greater than 30 minutes 6. Actively withdrawing from alcohol 3. Family history of schizophrenia or presence of psychotic symptoms

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Auburn University Auburn Alabama

Sponsors (2)

Lead Sponsor Collaborator
Auburn University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in attention switching MRI Task- analysis of behavioral data Baseline, immediately following TMS A, immediately following TMS B
Primary Change in sociomoral attention switching MRI Task- analysis of behavioral data Baseline, immediately following TMS A, immediately following TMS B
Primary Change in cue reactivity MRI Task- analysis of behavioral data Baseline, immediately following TMS A, immediately following TMS B
Secondary Change in brain activity attention switching MRI Task- analysis of imaging (fMRI) data Baseline, immediately following TMS A, immediately following TMS B
Secondary Change in brain activity during sociomoral attention switching MRI Task- analysis of imaging (fMRI) data Baseline, immediately following TMS A, immediately following TMS B
Secondary Change in brain activity during cue reactivity MRI Task- analysis of imaging (fMRI) data Baseline, immediately following TMS A, immediately following TMS B
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