Alcohol Use DisorderCNTNCT05621538
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
A study testing Realtime fMRI Neurofeedback - Active and TMS - Active in people with Alcohol Use Disorder, run by Auburn University at 1 site in United States.
Trial summary
The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Realtime fMRI Neurofeedback - Active and TMS - Active
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Mar 2026
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-65
- Receiving treatment for Alcohol Use Disorder
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
The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.
After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.
- Conditions
- Alcohol Use Disorder
- Being tested
- Realtime fMRI Neurofeedback - Active, TMS - Active, Realtime fMRI Neurofeedback - Yoked Sham, TMS - Sham
- Keywords
- treatment seeking, alcohol, TMS, neurofeedback, supplemental intervention, heavy drinking, problems with drinking
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realtime fMRI Neurofeedback - ActiveBehavioural
fMRI aided reinforcement of craving regulation
TMS - ActiveDevice
Also called Magventure Magpro
rTMS to right dorsolateral prefrontal cortex to reduce craving
Realtime fMRI Neurofeedback - Yoked ShamBehavioural
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
TMS - ShamDevice
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback-active + TMS-active | Experimental | 4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI) Receives: Behavioral: Realtime fMRI Neurofeedback - Active; Device: TMS - Active |
| Neurofeedback-active + TMS-sham | Active comparator | 4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI) Receives: Behavioral: Realtime fMRI Neurofeedback - Active; Device: TMS - Sham |
| Neurofeedback-sham + TMS-active | Active comparator | 4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI) Receives: Device: TMS - Active; Behavioral: Realtime fMRI Neurofeedback - Yoked Sham |
| Neurofeedback-sham + TMS-sham | Sham comparator | 4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI) Receives: Behavioral: Realtime fMRI Neurofeedback - Yoked Sham; Device: TMS - Sham |
| Check-In Only | No intervention | 4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use over Time
Alcohol Timeline Followback (alc-TLFB)
Measured: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Change in Alcohol Craving over Time
Alcohol Craving Questionnaire (ACQ)
Measured: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Change in Community Functioning over Time
Drinker Inventory of Consequences (DrInC)
Measured: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Change in Employment Status over Time
self-reported employment status
Measured: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Change in Aggression and Victimization over Time
Revised Conflict Tactics Scales (CTS-R)
Measured: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Change in Antisocial Behavior over Time
number of self-reported contacts with the police, convictions, and other criminal behaviors
Measured: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Change in Brain Activity during Alcohol Cue Presentation over Time
Measured via fMRI; standard alcohol cue reactivity
Measured: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
Measured via fMRI; alcohol-cued sociomoral processing
Measured: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Secondary outcomes (3)
Change in Brain Gray Matter Structure over Time
Measured via MRI; gray matter volume
Measured: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Brain White Matter Structure over Time
Measured via MRI; white matter diffusion
Measured: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Resting State Functional Connectivity over Time
Measured via fMRI
Measured: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Oct 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 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, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621538
- Sponsor's protocol ID
- 22145
- Other IDs
- R00AA027830
- Acronym
- CNT
- 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 within the NIAAA Data Archive according to the standard data sharing plan. Deidentified individual data regarding the outcome variables (clinical and MRI) will be included. Participants will have the option to opt out of sharing their individual data. Given the highly sensitive and confidential nature of the information, and the magnitude of potential harms to participants associated with disclosure, clinical outcome data pertaining to criminal acts and illegal activities will not be available in the data repository.
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
- ClinicalTrials.gov ID
- NCT05621538
- Acronym / sponsor ID
- CNT / 22145
- Conditions
- Alcohol Use Disorder
- Keywords
- treatment seeking, alcohol, TMS, neurofeedback, supplemental intervention, heavy drinking, problems with drinking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 18 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 goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.
After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback-active + TMS-active | Experimental | Behavioral: Realtime fMRI Neurofeedback - Active, Device: TMS - Active4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI) |
| Neurofeedback-active + TMS-sham | Active comparator | Behavioral: Realtime fMRI Neurofeedback - Active, Device: TMS - Sham4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI) |
| Neurofeedback-sham + TMS-active | Active comparator | Device: TMS - Active, Behavioral: Realtime fMRI Neurofeedback - Yoked Sham4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI) |
| Neurofeedback-sham + TMS-sham | Sham comparator | Behavioral: Realtime fMRI Neurofeedback - Yoked Sham, Device: TMS - Sham4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI) |
| Check-In Only | No intervention | –4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19-65
- Receiving treatment for Alcohol Use Disorder
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 |
|---|---|---|
| Realtime fMRI Neurofeedback - ActivefMRI aided reinforcement of craving regulation | Behavioural | Neurofeedback-active + TMS-active, Neurofeedback-active + TMS-sham |
| TMS - ActiveAlso: Magventure MagprorTMS to right dorsolateral prefrontal cortex to reduce craving | Device | Neurofeedback-active + TMS-active, Neurofeedback-sham + TMS-active |
| Realtime fMRI Neurofeedback - Yoked ShamDisplay of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation | Behavioural | Neurofeedback-sham + TMS-active, Neurofeedback-sham + TMS-sham |
| TMS - ShamrTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex | Device | Neurofeedback-active + TMS-sham, Neurofeedback-sham + TMS-sham |
Primary outcome
Change in Alcohol Use over Time
Time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Alcohol Timeline Followback (alc-TLFB)
Change in Alcohol Craving over Time
Time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Alcohol Craving Questionnaire (ACQ)
Change in Community Functioning over Time
Time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Drinker Inventory of Consequences (DrInC)
Change in Employment Status over Time
Time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
self-reported employment status
Change in Aggression and Victimization over Time
Time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Revised Conflict Tactics Scales (CTS-R)
Change in Antisocial Behavior over Time
Time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
number of self-reported contacts with the police, convictions, and other criminal behaviors
Change in Brain Activity during Alcohol Cue Presentation over Time
Time frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via fMRI; standard alcohol cue reactivity
Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
Time frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via fMRI; alcohol-cued sociomoral processing
3 secondary outcomes
Change in Brain Gray Matter Structure over Time
Time frame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Brain White Matter Structure over Time
Time frame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Resting State Functional Connectivity over Time
Time frame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
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 within the NIAAA Data Archive according to the standard data sharing plan. Deidentified individual data regarding the outcome variables (clinical and MRI) will be included. Participants will have the option to opt out of sharing their individual data. Given the highly sensitive and confidential nature of the information, and the magnitude of potential harms to participants associated with disclosure, clinical outcome data pertaining to criminal acts and illegal activities will not be available in the data 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.
Samantha J Fede, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Realtime fMRI Neurofeedback - Active and TMS - Active in people with Alcohol Use Disorder, 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 2 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. 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 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 Alcohol Use over Time (time frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)). The study lists 8 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.