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

项目摘要 本AA027705管理补充文件的主要目的是支付与数据相关的费用 根据NIAAA的要求进行共享。该项目的多个PI于2022年11月接管， 最初的项目PI离开了维克森林大学医学院。作为项目转移的一部分， 很明显，研究数据没有积极提交给国家酒精滥用研究所， 酒精中毒数据档案（NIAAADA）。不幸的是，当最初的赠款提案提交时， 没有要求支付与提交数据有关的费用。根据我们掌握的所有信息 收集了关于提交过程，我们对这个项目的数据的经验，事实上，我们的 数据字段采用NDA格式，NDA数据提交成本估算工具中的估算，我们有 确定了将要发生的费用。作为本行政管理的一部分，研究目的没有变化。 补充.该项目仍然是一项双盲、安慰剂对照、随机化研究，以评估相对于 2种潜在TBS治疗策略对AUD的疗效。具体而言，受试者将随机接受 将真实的或假TBS递送至腹侧内侧前额叶皮质（vmPFC）或背外侧前额叶皮质 （dlPFC）。主要结果指标仍然是禁欲天数百分比和重度 喝酒的日子次要结果测量包括渴望的变化和大脑反应的变化。 酒精暗示将使用功能性磁共振成像来测量。预算将涵盖 提交与研究主要和次要结局相关的所有数据的费用， 计划160名研究参与者。

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.