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.

项目概要/摘要 可卡因使用障碍 (CUD) 仍然是美国等地的一个重大公共卫生问题 需要有效的治疗策略。重复经颅磁刺激（rTMS）是一种非 调节特定大脑区域的侵入性方法，在治疗中已显示出初步疗效 CUD。然而，缺乏评估 CUD 中可卡因消耗量的假对照临床试验。 先前的 CUD 影像学研究表明前额皮质的广泛区域，包括 内侧前额叶皮质 (mPFC)、前扣带回皮质 (ACC) 和背外侧前额叶皮质 (dlPFC)。 连接性和皮质厚度的改变已被证明与 CUD 的治疗反应相关 跨越这些大脑区域的不同成像方式。因此，我们的目标是采用 rTMS，利用 H7-线圈，因为该线圈可以同时、双边刺激 mPFC 和背侧 ACC。此外， H7 线圈已获得 FDA 批准用于治疗强迫症 (OCD)，因为它能够达到这些目标 前额皮质内广泛、更深的区域。结果，发现了使用 H7 线圈的治疗中心 美国各地（50 个州中的 42 个州），这意味着该线圈的使用可以从实验室转移 到诊所的速度相对较快。 在此申请中，我们首先提出一项门诊双盲假对照试验（UG3 阶段） 使用功能磁共振成像研究 H7 线圈的可行性、大脑行为机制以及对开始戒断的影响 在认知行为治疗 (CBT) 之前服用可卡因。如果提议的通过/不通过标准 如果满足，我们将招募更大的样本来评估联合 rTMS/CBT 对戒断启动的功效 患有 CUD 的成人（UH3 期）。如果 UH3 数据支持治疗效果，这种治疗可以迅速 鉴于 FDA 现有 H7 线圈在精神病人群（即强迫症）中的许可，可转化为临床，以及 可能成为 FDA 批准的第一个 CUD 疗法。