Longitudinal Investigation of TMS as a Tool to Improve Alcohol Treatment Outcomes

Wake Forest University Health Sciences, Winston-Salem NC

Investigators

Linked publications & trials

Abstract

Project Summary The primary purpose of this administrative supplement to AA027705 is to cover the costs associated with data sharing as required by the NIAAA. The multi-PIs of this project took over in November of 2022 when the original project PI left Wake Forest University School of Medicine. As part of this project transfer, it became clear that study data was not actively being submitted to the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA). Unfortunately, when the original grant proposal was submitted, funds were not requested to cover the costs associated with data submission. Based on all the information we have gathered about the submission process, our experience with the data from this project, the fact that none of our data fields are in the NDA format, and estimates from NDA Data Submission Cost Estimation Tool, we have determined the costs that will be incurred. There are no changes in the study aims as part of this administrative supplement. The project remains a double-blind placebo controlled, randomized study to evaluate the relative efficacy of 2 potential TBS treatment strategies for AUD. Specifically, participants will be randomized to receive real or sham TBS delivered to the ventral medial prefrontal cortex (vmPFC), or dorsolateral prefrontal cortex (dlPFC). The primary outcome measures remain the percent days abstinent and the percentage of heavy drinking days. Secondary outcomes measures include changes in craving and change in brain response to alcohol cues will be measured using functional magnetic resonance imaging. The requested budget will cover the cost of submission of all the data relevant to the primary and secondary outcomes of the study from the planned 160 study participants.