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类药物成瘾者的认知能力，并可能 改善治疗效果。本研究的主要目的是测试经颅直流电是否 刺激（tDCS）可用于提高认知训练在增强阿片类药物认知方面的有效性 使用障碍来改善 OUD 治疗结果。 UG3阶段定位于FDA第一阶段 监管途径，我们将首次测试 tDCS + 认知训练的干预 使用随机对照试验设计的阿片类药物使用障碍 (OUD) 人群。 UG3 的目标是确定是否 干预：（A1）是安全可行的，（A2）在剂量依赖性中诱导基于电路的目标参与 以这种方式，（A3）产生认知的改善。我们将检查（A4）变化之间的关系 基于电路的目标的认知和变化。 UG3 的结果将为 UH3 的设计细节提供信息。 UH3 阶段将属于 FDA 监管途径的第二阶段。 UH3 目标将扩展 UG3 目标 通过检查干预措施对 (A5) 临床疗效（阿片类药物使用减少）、(A6) 持久性的影响 目标参与度、认知和临床疗效，以及 (A7) 探索个体建模的调节作用 tDCS 电场。在 UH3 阶段结束时，我们应该准备好设计进一步的第 2 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 通过让所有参与者接受随机认知训练来控制参与者的努力和时间 主动或假 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 次主动 tDCS 治疗的患者的 tDCS 剂量。脑成像， 认知和行为测量将进行 3 次：基线时、5 次会议后和 10 次会议后 会议。干预后 1 个月和 2 个月将收集后续认知和行为测量。 这将使我们能够检查目标参与度以及认知和行为影响。 UG3 里程碑 展示了：安全性、可行性、目标参与度和认知能力的提高。结果来自 UG3 将确定 UH3 的治疗次数。 UH3阶段将有100名参与者 招募以确定临床疗效和耐久性。脑成像、认知和行为测量将 进行 3 次：基线时、干预后以及 1 个月随访时。这将使我们能够 检查临床疗效（减少阿片类药物的使用）和干预措施的持久性。我们 UH3 的里程碑是 展示：临床疗效、持久性、目标参与度和衡量指标之间的关系 认知和药物使用行为（阿片类药物使用减少）。影响。认知障碍及其基础 神经机制影响成瘾治疗的结果。我们提出第一项研究来检验 tDCS- 增强认知训练会影响阿片类药物使用障碍的认知及其相关的大脑回路，从而设定 为未来大规模临床试验阶段。