A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
CNT
2 other identifiers
interventional
90
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedOctober 7, 2025
October 1, 2025
6 months
October 26, 2022
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Change in Alcohol Use over Time
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
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
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
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
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
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
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
Measured via fMRI; alcohol-cued sociomoral processing
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
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Brain White Matter Structure over Time
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Resting State Functional Connectivity over Time
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Study Arms (5)
Neurofeedback-active + TMS-active
EXPERIMENTAL4 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 COMPARATOR4 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 COMPARATOR4 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 COMPARATOR4 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 INTERVENTION4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)
Interventions
fMRI aided reinforcement of craving regulation
rTMS to right dorsolateral prefrontal cortex to reduce craving
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Eligibility Criteria
You may qualify if:
- Age 19-65
- Receiving treatment for Alcohol Use Disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Auburn University
Auburn, Alabama, 36849, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samantha J Fede, PhD
Auburn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- The PI will prospectively assign treatment groups with blind codes and so will not be blind to treatment type. Other staff, who are the individuals primarily working with the patients and who will be conducting follow-up interviews, will be blind to treatment type. It is not possible to blind the 5th condition (treatment as usual with a brief check-in).
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 26, 2022
First Posted
November 18, 2022
Study Start
October 1, 2025
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.