RCT of tDCS-Augmented CBT for Veterans with Pain and Opioid Misuse

描述(申请人提供)：慢性下腰痛(CLBP)是退伍军人中最常见的疼痛状况，与退伍军人退伍军人诊所高水平的阿片类止痛药处方有关。尽管处方阿片类药物对急性疼痛有效，但证据并不支持它们的长期有效性，它们与成瘾、转移注意力、过量服药和死亡的风险增加有关。在慢性疼痛的非药物治疗方面存在很大的差距，而且几乎没有科学证据来指导提供CRE。认知行为疗法(CBT)是目前应用最广泛的疼痛非药物治疗方法，但单独使用时对疼痛的影响不大。提高CBT的有效性和持久性对于为数百万患有慢性疼痛的退伍军人提供可行的非药物治疗选择至关重要。经颅直流电刺激(TDCS)是一种新型的微创脑刺激技术，当应用于背外侧前额叶皮质(DLPFC)时显示出镇痛效果。来自我们小组和其他人的积累数据表明，tdcs可能会增强CBT对慢性疼痛的治疗效果。然而，到目前为止，还没有研究直接调查联合使用这些疗法的潜在协同效应。这项拟议的研究直接解决了文献中的这一空白，通过测试tDCS与CBT联合使用在参加过持久自由行动、伊拉克自由行动或新黎明行动(OEF/OIF/OND)并患有CLBP和共病处方阿片使用障碍的美国退伍军人中减轻疼痛和阿片类药物使用严重程度的可行性和初步疗效。TDCs可以启动和调节前额叶回路，从而增强耐受和下调疼痛体验的情绪成分的能力，而CBT可以传授维持这些收益所需的技能，从而产生协同效应。的主要目标是 拟议的第二阶段研究将评估CBT和tDC在(1)改善疼痛和功能，(2)减轻阿片类药物使用障碍的严重程度，以及(3)减少相关精神健康领域(例如，其他物质和处方药的使用、抑郁、焦虑、创伤后应激障碍、睡眠)的损害方面的效果。为了实现这一点，我们使用基于证据的标准化CBT干预；采用组间随机双盲实验设计(CBT+tDCSvs CBT+Sham tDCs)；在5个时间点(治疗前和治疗后；1、3和6个月随访)检查标准化的、重复的依赖变化测量。该项目直接响应了国家药物滥用研究所(NIDA)和国家补充和替代医学中心(NCCAM)的使命，因为它寻求加快非药理学方法的临床试验研究，以控制疼痛和共病情况。这项研究的结果将提供经验证据，为更好地服务于美国军事人员和退伍军人需求的政策和计划提供参考。

DESCRIPTION (provided by applicant): Chronic low back pain (CLBP) is the most common pain condition among returning Veterans and is associated with high levels of opioid analgesic prescribing in VA clinics. Although prescription opioids are effective for acute pain, evidence does not support their long-term effectiveness and they are associated with increased risk of addiction, diversion, overdose and death. Substantial gaps in the non-pharmacologic treatment of chronic pain exist and there is little scientific evidence available to guide the provision of cre. Cognitive behavioral therapy (CBT) is the most widely used non-pharmacologic treatment for pain; however, its effects on pain are modest when used in isolation. Enhancing the effectiveness and durability of CBT is critical to providing a viable non-pharmacologic treatment option to the millions of Veterans suffering from chronic pain. Transcranial Direct Current Stimulation (tDCS) is a novel, minimally-invasive brain stimulation technique that demonstrates analgesic effects when applied over the dorsolateral prefrontal cortex (DLPFC). Accumulating data from our group and others suggest that tDCS may augment the treatment effects of CBT for chronic pain. However, no studies to date have directly investigated potential synergistic effects of combining these therapies. The proposed study directly addresses this gap in the literature by testing the feasibility and preliminary efficacy of tDCS in combination with CBT to reduce pain and opioid use severity among U.S. military Veterans who have served in Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn (OEF/OIF/OND) and have current CLBP and co-morbid prescription opioid use disorders. tDCS may prime and modulate prefrontal circuitry resulting in enhanced capacity to tolerate and down-regulate the emotional component of pain experience, while CBT can teach the skills necessary to maintain these gains, thus resulting in a synergistic effect. The primary objective of the proposed Stage II study is to evaluate the effects of CBT in combination with tDCS in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., other substance and prescription drug use, depression, anxiety, PTSD, sleep). To accomplish this we are: using a manualized, evidence-based CBT intervention; employing a randomized between-groups, double-blind experimental design (CBT + tDCS vs. CBT + sham tDCS); and examining standardized, repeated dependent measures of change at 5 time points (pre- and post-treatment; 1, 3 and 6 month follow-up). This project is directly responsive to the mission of the National Institute on Drug Abuse (NIDA) and the National Center for Complementary and Alternative Medicine (NCCAM) in that it seeks to accelerate clinical trial research on non-pharmacologic approaches to manage pain and comorbid conditions. The findings of this study will provide empirical evidence to inform polices and programs to better serve the needs of U.S. military personnel and Veterans.