Augmenting cognitive-behavioral therapy with rTMS of the medial prefrontal and anterior cingulate cortices for the treatment of cocaine use disorder

利用内侧前额叶和前扣带皮层的 rTMS 增强认知行为疗法治疗可卡因使用障碍

• 批准号: 10681981
• 负责人: Frances Rudnick Levin
• 金额: $ 72.89万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10681981
• 关键词: Abstinence; Adult; Anterior; Attention; Back; Behavior Therapy; Behavioral Mechanisms; Bilateral; Brain region; Cessation of life; Clinic; Clinical; Clinical Trials; Cocaine; Cocaine use disorder; Cognitive; Cognitive Therapy; Color; Consumption; Controlled Clinical Trials; Cues; Data; Dorsal; Double-Blind Method; Dropout; Drug usage; Exhibits; FDA approved; Frequencies; Functional Magnetic Resonance Imaging; Goals; Human; Impairment; Individual; Laboratories; Measures; Medial; Mental disorders; Methodology; Methods; Neurocognitive; Obsessive-Compulsive Disorder; Outcome; Outcome Measure; Outpatients; Participant; Patient Self-Report; Patients; Performance; Pharmaceutical Preparations; Phase; Population; Prefrontal Cortex; Public Health; Randomized; Refractory; Relapse; Safety; Sampling; Serious Adverse Event; Standardization; Stimulus; Thick; Translating; Treatment Efficacy; United States; Urine; Work; active method; benzoylecgonine; brain behavior; cingulate cortex; clinical outcome measures; cocaine use; comparison control; craving; cue reactivity; effective therapy; efficacy evaluation; experience; gray matter; imaging modality; imaging study; neural circuit; neuromechanism; placebo group; primary outcome; recruit; repetitive transcranial magnetic stimulation; response; safety and feasibility; success; therapy outcome; timeline; treatment arm; treatment center; treatment response; treatment strategy; volunteer; week trial

Project Summary/Abstract Cocaine use disorder (CUD) continues to be a significant public health problem in the U.S. and more effective treatment strategies are needed. Repetitive transcranial magnetic stimulation (rTMS) is a non- invasive method of modulating specific brain regions that has shown preliminary efficacy in the treatment of CUD. However, sham-controlled clinical trials assessing cocaine consumption in CUD are lacking. Previous imaging studies in CUD have implicated broad regions of the prefrontal cortex, including the medial prefrontal cortex (mPFC), anterior cingulate cortex (ACC), and dorsolateral prefrontal cortex (dlPFC). Alterations in connectivity and cortical thickness have been shown to correlate with treatment response in CUD across different imaging modalities in each of these brain regions. Thus, our goal is to employ rTMS, using the H7-coil, since this coil can simultaneously and bilaterally stimulate the mPFC and dorsal ACC. Additionally, the H7-coil has been FDA-cleared for obsessive-compulsive disorder (OCD), based on its ability to reach these broad, deeper regions within the prefrontal cortex. As a result, treatment centers using the H7-coil are found across the United States (in 42 of 50 states), meaning that the use of this coil could move from the laboratory to the clinic relatively quickly. In this application, we first propose an outpatient double-blind sham-controlled trial (UG3 Phase) to investigate H7-coil feasibility, brain-behavior mechanism(s) using fMRI, and effect on initiation of abstinence from cocaine when administered prior to cognitive behavioral therapy (CBT). If the proposed go/no-go criteria are met, we will recruit a larger sample to evaluate the efficacy of combined rTMS/CBT for abstinence initiation in adults with CUD (UH3 Phase). If the UH3 data support therapeutic efficacy, this treatment could rapidly translate to the clinic given existing FDA-clearance for the H7-coil in psychiatric populations (i.e., OCD), and could become the first FDA-approved therapy for CUD.

项目摘要/摘要 可卡因使用障碍（CUD）在美国仍然是一个重大的公共卫生问题，更多 需要有效的治疗策略。重复的经颅磁刺激（RTMS）是非 - 调节特定大脑区域的侵入性方法，该区域已显示在治疗中的初步疗效 库德。但是，缺乏评估可卡因消耗量的假手术临床试验。 CUD中以前的成像研究暗示了前额叶皮层的广泛区域，包括 内侧前额叶皮层（MPFC），前扣带回皮层（ACC）和背外侧前额叶皮层（DLPFC）。 连通性和皮质厚度的改变已显示与CUD的治疗反应相关 在每个大脑区域中的不同成像方式上。因此，我们的目标是使用RTMS，使用 H7线圈，因为该线圈可以同时和双侧刺激MPFC和背侧ACC。另外， H7-coil已根据强迫症（OCD）（OCD）的FDA清算，其基于其达到这些障碍的能力 前额叶皮层内的宽阔，更深的区域。结果，发现了使用H7线圈的治疗中心 在整个美国（50个州中的42个），这意味着该线圈的使用可以从实验室移动 相对较快地去诊所。 在此应用中，我们首先提出了门诊双盲假手术试验（UG3阶段） 使用fMRI调查H7型线圈的可行性，脑行为机制，并对禁欲的启动 在认知行为疗法（CBT）之前服用可卡因。如果拟议的执行/不执行标准 被满足，我们将招募更大的样本来评估RTMS/CBT合并的戒断功效 在患有CUD的成年人中（UH3期）。如果UH3数据支持治疗功效，则可以迅速 转换为诊所，鉴于精神病学种群中H7-coil现有的现有FDA清除率（即OCD）和 可能成为第一种FDA批准的CUD疗法。