Oxytocin to Enhance Alcohol Behavioral Couple Therapy

催产素增强酒精行为夫妻疗法

• 批准号: 10443676
• 负责人: JULIANNE Christina Flanagan
• 金额: $ 54.34万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-20 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10443676
• 关键词: Address; Aftercare; Alcohol consumption; Alcohol withdrawal syndrome; Alcohols; Animals; Area; Behavior; Behavior Therapy; Behavioral; Behavioral Mechanisms; Biological Markers; Cognitive; Communication; Conflict (Psychology); Couples; Couples Therapy; Cues; Data; Development; Distress; Double-Blind Method; Economic Burden; Ensure; Etiology; Experimental Designs; Female; Functional Magnetic Resonance Imaging; Functional disorder; Health Expenditures; Human; Impairment; Individual; Individual Differences; Intervention; Investigation; Literature; Measures; Mental Depression; Mental Health; Mission; National Institute on Alcohol Abuse and Alcoholism; Neurobiology; Neuropeptides; Outcome; Oxytocin; Pathway interactions; Patient Care; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Placebo Control; Placebos; Psychotherapy; Public Health; Randomized; Randomized Clinical Trials; Recording of previous events; Recovery; Relapse; Reporting; Research; Research Design; Rewards; Science; Severities; Social Environment; Standardization; Substance Use Disorder; Symptoms; Techniques; Therapeutic; Time; Translations; Treatment outcome; Trust; Withdrawal; addiction; alcohol abuse therapy; alcohol response; alcohol use disorder; arm; behavioral health; blood oxygen level dependent; brain circuitry; clinical practice; comparative efficacy; craving; efficacious treatment; efficacy evaluation; efficacy testing; evidence base; experimental group; follow-up; hazardous drinking; improved; individual patient; male; multidisciplinary; neurobiological mechanism; neuroimaging; novel; prognostic indicator; psychiatric comorbidity; psychosocial; public health priorities; reduced alcohol use; response; sex; skills; social; social cognition; treatment effect; treatment optimization; treatment response

ABSTRACT The development of effective pharmacotherapies to treat alcohol use disorder (AUD) is a public health priority. Few medications are currently approved to treat AUD and those that are remain limited by modest treatment responses. Combining pharmacological interventions with evidence-based behavioral interventions may help optimize treatment outcomes. While several effective behavioral interventions for AUD have been developed, the vast majority target individual patients, despite evidence that behavioral interventions for couples with AUD outperform individual treatments for AUD. Alcohol Behavioral Couples Therapy (ABCT) is an evidence-based behavioral intervention for couples that has been shown to significantly reduce AUD severity as well as improve relationship functioning, which is an important mechanism in treatment outcome for AUD. Accumulating evidence from our group and others suggests that oxytocin is a promising candidate pharmacotherapy to further enhance ABCT, reduce AUD severity and improve relationship functioning. Previous studies demonstrate oxytocin's ability to reduce craving, alcohol consumption, symptoms of tolerance and withdrawal, and ameliorate neurobiological deficits associated with AUD. Furthermore, oxytocin has been shown to increase prosocial factors (e.g., trust, social cognition) and restore sensitivity to natural rewards (e.g., intimate relationships). To date, no studies have examined the synergistic effects of combining oxytocin with ABCT in the treatment of AUD. Thus, the primary objective of this Stage II study is to examine the effects of oxytocin versus placebo in combination with ABCT in reducing AUD severity and improving relationship functioning. We will also utilize advanced neuroimaging techniques before and after treatment to investigate the underlying pathophysiology of AUD among couples and identify prognostic indicators of treatment outcome. To accomplish this, we will (1) employ a two-arm randomized, double-blind, between-groups experimental design that will consist of 12 weeks of ABCT treatment with oxytocin or placebo; (2) use standardized, repeated dependent measures of change including alcohol biomarkers at five time points (baseline, week 6, week 12, and 3- and 6-month follow-up); (3) measure impairment in associated mental and behavioral health problems (e.g., depression); and (4) use functional magnetic resonance imaging (fMRI) to examine changes in corticolimbic connectivity. The proposed study directly addresses the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in that it aims to examine the efficacy of a novel pharmacologic agent for the treatment of AUD. The findings from this study will provide critical new information to help inform clinical practice and accelerate research on the pharmacological treatment of AUD.

抽象的 开发有效治疗酒精饮酒障碍（AUD）的药物治疗是公共卫生的重点。 目前很少有药物被批准用于治疗AUD，并且那些受到适度治疗的限制的药物 回答。将药理学干预与基于证据的行为干预相结合可能有助于 优化治疗结果。尽管已经开发了几种有效的AUD行为干预措施 尽管有证据表明对AUD的夫妇的行为干预措施，但绝大多数人的目标 优于AUD的个人治疗。酒精行为夫妇治疗（ABCT）是一种基于证据的 夫妻的行为干预已被证明可显着降低AUD严重性并改善 关系功能，这是AUD治疗结果的重要机制。积累证据 来自我们的小组和其他人提出，催产素是一种有前途的候选药物治疗，可以进一步增强 ABCT，降低AUD严重性并改善关系功能。先前的研究表明催产素的能力 减少渴望，饮酒，耐受性和戒断症状以及改善神经生物学 与AUD相关的缺陷。此外，已经证明催产素可以增加亲社会因素（例如，信任， 社会认知）并恢复对自然奖励的敏感性（例如，亲密关系）。迄今为止，没有研究 检查了将催产素与ABCT结合在AUD治疗中的协同作用。因此，主要 本阶段研究的目的是检查催产素与安慰剂与ABCT的影响 降低AUD严重性并改善关系功能。我们还将利用高级神经影像学 治疗前后的技术研究了夫妻之间AUD的潜在病理生理学 确定治疗结果的预后指标。为此，我们将（1）使用两臂 随机，双盲，组间实验设计将包括12周的ABCT处理 催产素或安慰剂； （2）使用标准化的，重复的变化措施，包括酒精 五个时间点的生物标志物（基线，第6周，第12周以及3个月和6个月的随访）； （3）测量 相关的心理和行为健康问题受损（例如抑郁症）； （4）使用功能 磁共振成像（fMRI）以检查皮质降低连通性的变化。拟议的研究 直接解决了美国国家酒精滥用与酒精中毒研究所（NIAAA）的使命，因为它旨在 检查新型药理学剂对AUD治疗的功效。这项研究的发现 将提供关键的新信息，以帮助为临床实践提供信息，并加速有关 AUD的药理治疗。