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

TMS 作为改善酒精治疗结果工具的纵向调查

• 批准号: 10844805
• 负责人: Merideth A. Addicott
• 金额: $ 4.17万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10844805
• 关键词: Administrative Supplement; Applications Grants; Brain; Budgets; Data; Double-Blind Method; Functional Magnetic Resonance Imaging; Funding; Goals; Heavy Drinking; Interdisciplinary Study; Investigation; Left; Measures; Medial; National Institute on Alcohol Abuse and Alcoholism; Outcome Measure; Outcome Study; Participant; Prefrontal Cortex; Process; Randomized; Treatment Protocols; Treatment outcome; Universities; alcohol abuse therapy; alcohol cue; alcohol response; brain based; cost; cost estimate; craving; data archive; data sharing; data submission; evidence base; experience; forest; improved; medical schools; primary outcome; randomized placebo controlled study; secondary outcome; tool; treatment strategy

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.

项目摘要 AA027705的这一行政补充的主要目的是涵盖与数据相关的成本 按照NIAAA的要求进行共享。该项目的多项绩效指标于2022年11月接管，当时 最初的项目Pi离开了维克森林大学医学院。作为这个项目转移的一部分，它成为了 很明显，研究数据没有积极提交给国家酒精滥用研究所和 酒精中毒数据档案(NIAAADA)。不幸的是，当最初的拨款提案提交时，资金 没有被要求支付与数据提交相关的费用。根据我们掌握的所有信息 收集有关提交过程的信息，我们使用此项目数据的经验，我们的 数据字段是NDA格式的，NDA数据提交成本估算工具中的估算，我们有 已确定将产生的成本。作为这项行政管理的一部分，研究目标没有变化 副刊。该项目仍然是一项双盲、安慰剂对照、随机研究，以评估亲属 AUD两种潜在TBS治疗策略的疗效比较具体地说，参与者将被随机接受 真实或假的TBS传递到腹侧前额叶皮质(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戒断天数百分比 喝酒的日子。次级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磁共振成像进行测量。申请的预算将包括 提交与研究的主要和次要结果有关的所有数据的费用 计划160名研究参与者。