Non-invasive Vagal Nerve Stimulation to improve functional outcomes in Veterans with Alcohol Use Disorder

无创迷走神经刺激可改善患有酒精使用障碍的退伍军人的功能结果

• 批准号: 10613308
• 负责人: Ruth Klaming
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10613308
• 关键词: Abstinence; Address; Affect; Affective; Alcohol consumption; Alcohols; Analgesics; Animal Model; Animals; Anxiety; Applications Grants; Attenuated; Autonomic nervous system; Award; Awareness; Behavior assessment; Brain region; Caring; Chronic; Clinical; Clinical Research; Cognitive; Data; Data Collection; Development; Diagnosis; Distress; Dropout; Effectiveness; Emotional; Employment; Equipment and supply inventories; Feasibility Studies; Functional Magnetic Resonance Imaging; Functional disorder; Funding; Goals; Health; Healthcare Systems; Heavy Drinking; Home; Homeostasis; Human; Impairment; Infrastructure; Insula of Reil; Intervention; Interview; Measures; Mental Depression; Mental disorders; Nerve; Neurosciences; Outcome; Pain; Pain interference; Pathway interactions; Patients; Pattern; Perception; Pharmaceutical Preparations; Pharmacotherapy; Physiological; Population; Post-Traumatic Stress Disorders; Productivity; Psychotherapy; Quality of life; Questionnaires; Randomized; Recovery; Rehabilitation therapy; Relapse; Research; Research Personnel; Risk; Sampling; Self Administration; Self Care; Services; Stimulus; Stress; Structure; Symptoms; Technology; Time; Training; Translating; Treatment Cost; Vagus nerve structure; Veterans; Visit; Work; acceptability and feasibility; addiction; alcohol abuse therapy; alcohol craving; alcohol exposure; alcohol rehabilitation; alcohol relapse; alcohol use disorder; alternative treatment; bodily sensation; career; chronic pain; community reintegration; cost; craving; design; diaries; drinking; drug relapse; efficacy evaluation; efficacy testing; emotional distress; experience; follow-up; functional disability; functional improvement; heat stimulus; improved; innovation; military veteran; negative affect; neural; neural correlate; neuroadaptation; neuroregulation; novel; physical state; psychologic; psychological distress; psychosocial; randomized, clinical trials; recruit; reduce symptoms; response; side effect; social stigma; substance use; transmission process; treatment adherence; treatment risk

Alcohol use disorder (AUD) is a serious mental health disorder that affects more than 40% of US military Veterans, presenting a major burden to this population and to the VA Healthcare System. Relapse rates of AUD are extremely high; over half of Veterans who complete treatment relapse within 6 months, highlighting the need for improved treatments or differing treatment targets. Chronic, heavy drinking leads to an imbalance in homeostasis resulting in psychological and physical distress during periods of abstinence, and the urge to drink to relieve these symptoms to restore homeostasis. Noninvasive vagal nerve stimulation (nVNS) is a low-risk form of neuromodulation that has been shown to alleviate anxiety and chronic pain, and to reduce drug and alcohol relapse in animal models. We hypothesize that nVNS attenuates distress-related craving in AUD in humans by modifying the autonomic nervous system and changing the perception of inner bodily sensations of physiological and affective distress. We also hypothesize that nVNS improves functional outcomes and quality of life in Veterans with AUD. The proposed research will utilize the infrastructure of an ongoing VA-funded study by adding a small subsample of Veterans who meet for a diagnosis of AUD (with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking). Subjects will be randomly assigned to receive nVNS or sham stimulation prior to performing a well-validated functional Magnetic Resonance Imaging task designed to assess neural correlates of physical distress (via a heat stimulus). Subjects will then self-administer nVNS/sham at home twice a day for 7 days and return for a follow-up visit, during which all study components will be repeated. Behavioral assessments of functional disability, quality of life, psychological and physiological distress, and craving will be administered at baseline, after stimulation, and at follow-up. The aim of the proposed study is to establish feasibility and acceptability of applying nVNS as a rehabilitative treatment for AUD. In addition, the study will evaluate the preliminary effectiveness of nVNS in improving functional outcomes and quality of life, in reducing distress and craving, and in altering neural activation patterns in brain regions involved in the perception and awareness of distress and pain. The proposed work has the potential to lead to innovative, low-risk treatment options with high promise to significantly improve the care and lives of Veterans as there is a need for alternative treatments for AUD. As such, this novel AUD treatment could be particularly beneficial for Veterans who do not tolerate pharmacotherapy, and who have access or cognitive limitations or stigma concerns that act as barriers to psychotherapy. The immediate career goal for this CDA-1 award is to provide the applicant with the clinical research experience and the pilot data necessary for a competitive CDA-2 grant application aimed at testing the efficacy of nVNS as a treatment option for AUD-related symptoms and functional rehabilitation in a larger sample, and to address mechanisms of action. The long-term goal is to guide the applicant’s development toward becoming a productive clinical researcher within the VA Healthcare System with expertise in neuroscience-based rehabilitation of AUD.

酒精使用障碍（AUD）是一种严重的心理健康障碍，影响着超过40%的美国军人