A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder (CNT)

October 2, 2025 updated by: Samantha Fede, Auburn University

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Recruiting
        • Auburn University
        • Contact:
        • Principal Investigator:
          • Samantha J Fede, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 19-65
  2. Receiving treatment for Alcohol Use Disorder

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofeedback-active + TMS-active
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)
Behavioral: Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
Device: TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
Other Names:
  • Magventure Magpro
Active Comparator: Neurofeedback-active + TMS-sham
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)
Behavioral: Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
Device: TMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Active Comparator: Neurofeedback-sham + TMS-active
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)
Device: TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
Other Names:
  • Magventure Magpro
Behavioral: Realtime fMRI Neurofeedback - Yoked Sham
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
Sham Comparator: Neurofeedback-sham + TMS-sham
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)
Device: TMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Behavioral: Realtime fMRI Neurofeedback - Yoked Sham
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
No Intervention: Check-In Only
4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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
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
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)
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
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
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
Time Frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via fMRI; standard alcohol cue reactivity
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
Time Frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via fMRI; alcohol-cued sociomoral processing
Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brain Gray Matter Structure over Time
Time Frame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Measured via MRI; gray matter volume
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)
Measured via MRI; white matter diffusion
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)
Measured via fMRI
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auburn University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Samantha J Fede, PhD, Auburn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22145
  • R00AA027830 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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