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.

项目总结/文摘