Combined tDCS and Cognitive Training for the Treatment of Opioid Addiction

经颅直流电刺激 (tDCS) 和认知训练相结合治疗阿片类药物成瘾

• 批准号: 9750304
• 负责人: KELVIN O. LIM
• 金额: $ 35.88万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9750304
• 关键词: Abstinence; Adaptive Behaviors; Affect; Alcohol or Other Drugs use; Automobile Driving; Behavior; Brain imaging; Chronic; Clinical Trials; Cognition; Cognitive; Corpus striatum structure; Coupled; Data; Dose; Double-Blind Method; Effectiveness; Electric Stimulation; Epidemic; Future; Goals; Impaired cognition; Individual; Intervention; Intervention Studies; Measures; Mediating; Modeling; Opiate Addiction; Parietal; Participant; Patients; Phase; Population; Positioning Attribute; Prefrontal Cortex; Randomized; Recovery; Regulatory Pathway; Relapse; Reporting; Rest; Testing; Thalamic structure; Time; Treatment outcome; United States; addiction; alcohol abstinence; alcohol use disorder; base; behavior measurement; brain circuitry; clinical efficacy; cognitive control; cognitive training; design; drug use behavior; electric field; experimental study; follow-up; improved; intervention effect; neural network; neuromechanism; opioid misuse; opioid use; opioid use disorder; prescription opioid; recruit; relating to nervous system; safety and feasibility

Evidence suggests that cognitive training can improve cognition in individuals with opioid addiction and may improve treatment outcome.The primary objective of this study is to test whether transcranial direct current stimulation (tDCS) can be used to boost the effectiveness of cognitive training in enhancing cognition in opioid use disorder to improve OUD treatment outcome. The UG3 phase is positioned to be in Phase 1 of the FDA Regulatory Pathway in which we will test for the first time the intervention of tDCS + cognitive training in a population with opioid use disorder (OUD) using an RCT design. The UG3 Aims are to determine if the intervention: (A1) is safe and feasible, (A2) induces circuit-based target engagement in a dose dependent manner, (A3) produces improvement in cognition. We will examine (A4) the relationship between changes in cognition and changes in the circuit-based target. Results from the UG3 will inform design details for the UH3. The UH3 phase will be in Phase 2 of the FDA Regulatory Pathway. The UH3 Aims will expand on UG3 aims by examining the effect of the intervention on (A5) clinical efficacy (decreased opioid use), (A6) durability of target engagement, cognition and clinical efficacy, and (A7) explore moderation effect of individually modeled tDCS electric field. At the end of the UH3 phase, we should be positioned to design either a further Phase 2 or 3 Clinical Trial to support a Premarket Approval application. Our double-blind randomized controlled design controls for participant effort and time by having all participants receive cognitive training with randomization to either active or sham tDCS. In the UG3 phase, 30 participants with OUD will be recruited to study the effect of tDCS dose by contrasting those that received 5 vs 10 treatment sessions of active tDCS. Brain imaging, cognitive and behavioral measures will be conducted three times: at baseline, after 5 sessions, and after 10 sessions. Follow-up cognitive and behavioral measures will be collected 1 and 2 months after intervention. This will allow us to examine target engagement, as well as cognition and behavior effects. UG3 milestones are the demonstration of: safety, feasibility, target engagement, and improvement in cognition. Results from the UG3 will determine the number of treatment sessions.for UH3. In the UH3 phase, 100 participants will be recruited to determine clinical efficacy and durability. Brain imaging, cognitive and behavioral measures will be conducted three times: at baseline, after the intervention, and at 1 month follow-up. This will allow us to examine clinical efficacy (decreased opioid use) and durability of the intervention. Our milestones for UH3 are the demonstration of: clinical efficacy, durability, relationship between target engagement and measures of cognition and drug use behavior (decreased opioid use). Impact. Cognitive impairments and its underlying neural mechanisms affect addiction treatment outcomes. We propose the first study to examine how tDCS- augmented cognitive training affects cognition and its related brain circuitry in opioid use disorder, setting the stage for future large scale clinical trials.

有证据表明，认知训练可以改善阿片成瘾患者的认知能力，并可能 改善治疗结果。本研究的主要目的是测试经颅直流电 刺激(TDCs)可用于提高认知训练的有效性，从而增强阿片类药物的认知能力 使用障碍改善OUD治疗结果。UG3阶段被定位为FDA的第一阶段 我们将首次测试tdcs+认知训练对 使用随机对照试验设计的阿片类药物使用障碍人群(OUD)。UG3的目标是确定是否 干预：(A1)是安全可行的，(A2)以剂量依赖的方式诱导基于电路的靶参与 方式，(A3)在认知方面产生改善。我们将研究(A4)以下变化之间的关系 对电路型靶标的认识和变化。UG3的结果将为UH3的设计细节提供信息。 UH3阶段将处于FDA监管途径的第二阶段。UH3目标将在UG3目标的基础上扩展 通过检查干预对(A5)临床疗效(减少阿片类药物使用)、(A6)阿片类药物耐受性的影响 目标投入、认知和临床疗效，以及(A7)探索个人建模的调节效应 TDCS场。在UH3阶段结束时，我们应该能够设计进一步的第二阶段或 3支持上市前批准申请的临床试验。我们的双盲随机对照设计 通过让所有参与者随机接受认知培训来控制参与者的努力和时间 活动的或假的tdcs。在UG3阶段，将招募30名患有OUD的参与者来研究 通过对比接受5次和10次活性TDC治疗的患者的TDCs剂量。大脑成像， 认知和行为测量将进行三次：在基线、5次会议之后和10次之后 会话。在干预后1个月和2个月收集后续的认知和行为测量。 这将使我们能够检查目标参与，以及认知和行为影响。UG3里程碑 是对安全性、可行性、目标交战和认知改善的证明。结果来自 UG3将决定UH3的治疗疗程数。在UH3阶段，将有100名参与者 招募以确定临床疗效和耐受性。脑成像、认知和行为测量将是 共进行3次：基线、干预后、1个月随访。这将使我们能够 检查临床疗效(减少阿片类药物的使用)和干预的持久性。我们UH3的里程碑是 论证：临床疗效、耐受性、目标参与度与治疗措施的关系 认知和药物使用行为(阿片类药物使用减少)。冲击力。认知障碍及其潜在原因 神经机制影响成瘾治疗结果。我们建议进行第一项研究，以考察tdcs是如何- 增强认知训练影响阿片类药物使用障碍的认知及其相关脑回路，设置 为未来大规模临床试验做准备。