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.

项目概要 AA027705 的行政补充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，当时 原项目PI离开维克森林大学医学院。作为该项目转让的一部分，它成为 明确研究数据没有积极提交给国家酒精滥用研究所，并且 酗酒数据档案 (NIAADA)。不幸的是，当最初的拨款提案提交时，资金 没有被要求承担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、我们对该项目数据的经验、事实上我们没有 数据字段采用 NDA 格式，并通过 NDA 数据提交成本估算工具进行估算，我们有 确定将产生的费用。作为本次行政管理的一部分，研究目标没有变化 补充。该项目仍然是一项双盲安慰剂对照随机研究，以评估相对 2 种潜在的 TBS 治疗策略对 AUD 的疗效。具体来说，参与者将被随机分配接受 真实或假 TBS 传递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禁欲天数百分比 喝酒的日子。次要结果指标包括渴望的变化和大脑反应的变化 酒精线索将使用功能性磁共振成像进行测量。请求的预算将涵盖 提交与研究的主要和次要结果相关的所有数据的费用 计划有 160 名研究参与者。