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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
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
Auburn University
Auburn, Alabama, United States
RECRUITINGChange in Alcohol Use over Time
Alcohol Timeline Followback (alc-TLFB)
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)
Change in Alcohol Craving over Time
Alcohol Craving Questionnaire (ACQ)
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)
Change in Community Functioning over Time
Drinker Inventory of Consequences (DrInC)
Time frame: 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
Time frame: 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)
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)
Change in Antisocial Behavior over Time
number of self-reported contacts with the police, convictions, and other criminal behaviors
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)
Change in Brain Activity during Alcohol Cue Presentation over Time
Measured via fMRI; standard alcohol cue reactivity
Time frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
Measured via fMRI; alcohol-cued sociomoral processing
Time frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Brain Gray Matter Structure over Time
Measured via MRI; gray matter volume
Time frame: 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
Time frame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Change in Resting State Functional Connectivity over Time
Measured via fMRI
Time frame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)