Oxytocin to Enhance Alcohol Behavioral Couple Therapy

催产素增强酒精行为夫妻疗法

基本信息

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
项目类别：
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

项目摘要

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.

抽象的开发有效的药物疗法来治疗酒精使用障碍（AUD）是公共卫生的首要任务。目前很少有药物被批准用于治疗 AUD，并且那些药物仍然受到适度治疗的限制回应。将药物干预与基于证据的行为干预相结合可能会有所帮助优化治疗结果。虽然已经开发出几种有效的 AUD 行为干预措施，尽管有证据表明对患有 AUD 的夫妇进行行为干预，但绝大多数都是针对个体患者优于 AUD 的个体治疗。酒精行为夫妻疗法（ABCT）是一种基于证据的疗法对夫妻的行为干预已被证明可以显着降低 AUD 的严重程度并改善关系功能，这是 AUD 治疗结果的重要机制。积累证据我们小组和其他人的研究表明，催产素是一种有前途的候选药物疗法，可以进一步增强 ABCT，降低 AUD 严重性并改善关系功能。先前的研究证明了催产素的能力减少渴望、饮酒、耐受和戒断症状，并改善神经生物学与澳元相关的赤字。此外，催产素已被证明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（例如亲密关系）的敏感性。迄今为止，还没有研究表明检查了催产素与 ABCT 联合治疗 AUD 的协同作用。因此，初级该第二阶段研究的目的是检查催产素与安慰剂联合 ABCT 的效果降低 AUD 严重性并改善关系功能。我们还将利用先进的神经影像学治疗前后的技术，以调查夫妻之间 AUD 的潜在病理生理学确定治疗结果的预后指标。为了实现这一目标，我们将（1）采用双臂随机、双盲、组间实验设计，包括 12 周的 ABCT 治疗使用催产素或安慰剂； (2) 使用标准化、重复依赖的改变措施，包括酒精五个时间点（基线、第 6 周、第 12 周以及 3 个月和 6 个月随访）的生物标志物； (3)测量相关精神和行为健康问题（例如抑郁症）受损； (4) 使用函数磁共振成像（fMRI）检查皮质边缘连接的变化。拟议的研究直接阐述了国家酒精滥用和酒精中毒研究所 (NIAAA) 的使命，其目标是检验一种新型药物治疗 AUD 的疗效。这项研究的结果将提供重要的新信息，以帮助指导临床实践并加速相关研究 AUD的药物治疗。