An Exploratory Investigation Utilizing Repetitive Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning in Veterans with Opioid Use Disorder

一项利用重复经颅磁刺激 (rTMS) 作为减少阿片类药物使用障碍退伍军人疼痛和改善功能的工具的探索性研究

• 批准号: 9918168
• 负责人: AIMEE L MCRAE-CLARK
• 金额: --
• 依托单位: RALPH H JOHNSON VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9918168
• 关键词: Abstinence; Acute; Affective; Alcohol or Other Drugs use; Alcohols; Anxiety; Blinded; Brain; Buprenorphine; Clinical; Clinical Trials; Cocaine; Cross-Over Trials; Cues; Data; Disease; Double-Blind Method; FDA approved; Future; General Population; Goals; Healthcare Systems; Individual; Intervention; Investigation; Laboratories; Literature; Major Depressive Disorder; Measurement; Mechanics; Medical center; Mental Depression; Middle East; Morbidity - disease rate; Morphine; Nicotine; Opiate Addiction; Opioid; Opioid replacement therapy; Outcome; Pain; Pain Threshold; Participant; Patients; Perception; Pilot Projects; Population; Post-Traumatic Stress Disorders; Prefrontal Cortex; Preparation; Randomized; Recovery; Relapse; Reporting; Self Administration; Sensory; Sleep; Smoker; Substance Use Disorder; Techniques; Translating; Treatment outcome; Veterans; Visit; Work; alcohol use disorder; bariatric surgery; base; chronic pain; chronic pain patient; chronic painful condition; clinically relevant; cocaine use; cohort; community reintegration; comorbidity; craving; effective therapy; follow-up; functional outcomes; improved; improved functioning; mortality; neuroregulation; nicotine use; novel; opioid abuse; opioid overdose; opioid use; opioid use disorder; pain reduction; pain sensitivity; programs; repetitive transcranial magnetic stimulation; tobacco abstinence; tool; treatment effect

Opioid use disorders (OUDs) are common among Veterans. Despite the availability of opioid replacement therapies, many individuals continue to abuse opioids and relapse rates remain high. Veterans are nearly twice as likely to die from accidental opioid overdose than the general population. Approximately 60% of Veterans returning from the Middle East and more than 50% of older Veterans in the VA health care system have chronic pain. Further, post-traumatic stress disorder, a common comorbidity in the Veteran population, has been shown to negatively impact early engagement and retention of individuals in OUD treatment. As is the case with other substance use disorders, opioid craving is commonly described by abstinent patients whether or not they are stabilized on buprenorphine (Northrup et al., 2015; Tsui et al., 2014). Subsequently, a treatment that reduces pain and craving, while also improving early engagement and retention in treatment, would improve recovery from opioid addiction. Repetitive Transcranial Magnetic Stimulation (rTMS) is capable of non-invasively altering cortical function. rTMS is an FDA-approved treatment for major depressive disorder. Preliminary evidence suggests that rTMS can also reduce pain in chronic pain conditions and craving in substance use disorders. Single sessions of rTMS produce small temporary effects, while multiple sessions of rTMS result in larger, more durable effects. Our group recently completed a blinded, sham-controlled crossover trial in non-treatment seeking OUD participants. A single session of rTMS reduced cue-induced craving and increased thermal pain thresholds. Given that multiple sessions of rTMS produce larger and more durable treatment effects than single sessions of rTMS, it follows that multiple treatment sessions applied to OUD patients may result in a clinically relevant reduction in pain and cue- induced craving, which could improve clinical and functional outcomes. In this SPiRE pilot proposal, we will perform a randomized, double-blind, sham-controlled trial delivering an accelerated course of rTMS to a cohort of OUD Veterans with chronic pain receiving treatment through the Ralph H. Johnson VA Medical Center Substance Treatment and Recovery program. The goal of this proposal is to evaluate the feasibility and acceptability of delivering rTMS to the dorsolateral pre-frontal cortex in Veterans with OUD and chronic pain. We will also preliminarily explore the feasibility of evaluating potential outcome measurements in preparation for a larger trial, including abstinence, treatment retention, community reintegration and functional outcomes, pain, and opioid craving. Positive results from this pilot project will inform a future MERIT application and have the potential to significantly improve treatment outcomes in this difficult to treat Veteran population.

阿片类药物使用障碍（OUD）在退伍军人中很常见。尽管替代了阿片类药物 疗法，许多人继续滥用阿片类药物，复发率仍然很高。退伍军人几乎是两次 与普通人群相比，因意外阿片类药物过量而死亡的可能性。大约60％的退伍军人 VA卫生保健系统中从中东返回，超过50％的老兵有慢性 疼痛。此外，已经显示了创伤后应激障碍是退伍军人人口的常见合并症 负面影响在Oud治疗中的早期参与和保留个人。与其他情况一样 药物使用障碍，戒酒患者通常描述阿片类药物的渴望，无论他们是否是 稳定在丁丙诺啡上（Northrup等，2015； Tsui等，2014）。随后，一种减少的治疗 疼痛和渴望，同时也可以改善早期参与度和治疗中的保留率，将改善康复 来自阿片类药物成瘾。 重复的经颅磁刺激（RTMS）能够无创地改变皮质功能。 RTMS 是FDA批准的主要抑郁症治疗方法。初步证据表明RTM也可以 减轻慢性疼痛状况的疼痛，并渴望在药物使用障碍中。 RTMS的单次会议 小临时效应，而多次RTM会导致更大，更耐用的效果。我们的小组最近 在非治疗的参与者中完成了一项盲目的，虚假控制的跨界试验。一个 RTMS的疗程减少了提示引起的渴望和增加的热疼痛阈值。鉴于那个倍数 RTMS的会话比RTMS的单个会话产生更大，更耐用的治疗效果，因此 适用于OUD患者的多次治疗课程可能会导致疼痛和提示与临床相关的减少 诱发的渴望可以改善临床和功能结果。 在这个尖顶试点建议中，我们将执行一项随机，双盲，假对照试验，以提供 加速RTMS的过程加入了一批通过Ralph接受慢性疼痛接受治疗的Oud退伍军人队列 H. Johnson VA医疗中心物质治疗和恢复计划。该提议的目的是 评估将RTM递送到退伍军人的背外侧前额外皮层的可行性和可接受性 Oud和慢性疼痛。我们还将初步探索评估潜在结果的可行性 准备大型试验的测量值，包括禁欲，治疗保留，社区重返社会 以及功能性结果，疼痛和阿片类药物的渴望。该试点项目的积极结果将为未来提供信息 值得应用，并有可能在难以治疗的情况下显着改善治疗结果 资深人口。