NCT05621538 · Auburn University
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
(CNT)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
DEVICE
TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
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
DEVICE
TMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Auburn, Alabama
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2025 · Source of record for eligibility and locations