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NCT Number: NCT05621538

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

Location status: Recruiting

Location contact

SCAMPI Lab

CONTACT

[email protected]

334-521-2807

Samantha J Fede, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19-65
  • Receiving treatment for Alcohol Use Disorder

Exclusion criteria

  • 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

Treatment and study plan

Realtime fMRI Neurofeedback - Active

Behavioral

fMRI aided reinforcement of craving regulation

TMS - Active

Device

rTMS to right dorsolateral prefrontal cortex to reduce craving

Other names: Magventure Magpro

Realtime fMRI Neurofeedback - Yoked Sham

Behavioral

Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation

TMS - Sham

Device

rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

SCAMPI Lab

CONTACT

[email protected]

334-521-2807

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: CNT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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