Drinking, AlcoholTAMNCT05611502
Influence of TMS on Attention Modulation
A study testing TMS in people with Drinking, Alcohol, run by Auburn University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drinking, Alcohol
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 31 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
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
Auburn University
Auburn, Alabama, 36849
SCAMPI Lab, 334-521-2807, scampi@auburn.edu
Samantha J Fede, PhD
About this study
Official title: A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2
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.
- Conditions
- Drinking, Alcohol
- Being tested
- TMS
- Keywords
- alcohol, attention, TMS, binge drinking, emotion, social cognition, moral, MRI, frontal eye fields, moral cognition
- Medical subject headings
- Alcohol Drinking, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called Magventure MagPro
TMS will be administered in a pattern that is either excitatory or inhibitory.
| Study group | Role | What they receive |
|---|---|---|
| TMS A | Experimental | TMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI Receives: 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 Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention switching
MRI Task- analysis of behavioral data
Measured: Baseline, immediately following TMS A, immediately following TMS B
Change in sociomoral attention switching
MRI Task- analysis of behavioral data
Measured: Baseline, immediately following TMS A, immediately following TMS B
Change in cue reactivity
MRI Task- analysis of behavioral data
Measured: Baseline, immediately following TMS A, immediately following TMS B
Secondary outcomes (3)
Change in brain activity attention switching
MRI Task- analysis of imaging (fMRI) data
Measured: Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during sociomoral attention switching
MRI Task- analysis of imaging (fMRI) data
Measured: Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during cue reactivity
MRI Task- analysis of imaging (fMRI) data
Measured: Baseline, immediately following TMS A, immediately following TMS B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start11 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drinking, AlcoholStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Samantha Fede, Auburn University
- Investigators
- Samantha J Fede, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611502
- Sponsor's protocol ID
- 21510
- Other IDs
- R00AA027830
- Acronym
- TAM
- Status last verified
- Oct 2025
- First submitted
- 26 Oct 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Neurofeedback- TMS Intervention for Alcohol Use Disorder - Aim 2
- ClinicalTrials.gov ID
- NCT05611502
- Acronym / sponsor ID
- TAM / 21510
- Conditions
- Drinking, Alcohol
- Keywords
- alcohol, attention, TMS, binge drinking, emotion, social cognition, moral, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Nov 2022 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive each arm in counterbalanced order (AB or BA).
| Arm | Type | Receives |
|---|---|---|
| TMS A | Experimental | Device: TMSTMS administered over right frontal eye field at 10 Hz, 110% of MT, 60 x 5 sec trains, 25 sec ITI |
| TMS B | Active comparator | Device: TMSTMS administered over right frontal eye field at 1 Hz, 110% of MT, 7 x 225 sec trains, 30 sec ITI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- MRI Contraindications
- TMS Contraindications
- Family history of schizophrenia or presence of psychotic symptoms
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 |
|---|---|---|
| TMSAlso: Magventure MagProTMS will be administered in a pattern that is either excitatory or inhibitory. | Device | TMS A, TMS B |
Primary outcome
Change in attention switching
Time frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Change in sociomoral attention switching
Time frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
Change in cue reactivity
Time frame: Baseline, immediately following TMS A, immediately following TMS B
MRI Task- analysis of behavioral data
3 secondary outcomes
Change in brain activity attention switching
Time frame: Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during sociomoral attention switching
Time frame: Baseline, immediately following TMS A, immediately following TMS B
Change in brain activity during cue reactivity
Time frame: Baseline, immediately following TMS A, immediately following TMS B
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 7 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
Samantha J Fede, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Drinking, Alcohol, run by Auburn University 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 3 inclusion and 12 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 7 Oct 2025. 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. 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 SCAMPI Lab (334-521-2807, scampi@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in attention switching (time frame: Baseline, immediately following TMS A, immediately following TMS B). 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 7 Oct 2025.