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临床试验/NCT03056872
NCT03056872已完成不适用

Physiological Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes

University of Minnesota1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Relapse Severity

研究概览

简要总结

Alcohol dependence is among the most common and costly public health problems affecting the nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months following AUD treatment. Dysregulation of biological stress-mood systems predict and correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation correlates with improved AUD treatment outcomes but has not been examined with respect to AUD recovery and relapse in co-occurring AUD+AnxD.

详细描述

The objectives of the proposed research are to 1) evaluate the effect of co-occurring AnxD on the severity of biological stress-mood system dysregulations in AUD inpatients at pre-treatment, 2) evaluate the effect of co-occurring AnxD on the persistence of stress-mood system dysregulations in AUD inpatients in the months following treatment, 3) evaluate the effects of treatment on biological stress-mood system re-regulation among AUD patients with co-occurring AnxD, and 4) evaluate the effect of re-regulation change in biological stress-mood system function on AUD clinical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to provide informed consent
  • Between the ages of 18 and 65
  • Diagnostic and Statistical Manual diagnosis of a Panic Disorder, Generalized Anxiety Disorder, or Social Anxiety Disorder within the past 30 days (AUD+AnxD group only).
  • Primary alcohol use disorder diagnosis and alcohol use in the 30 days preceding the study (AUD alone and AUD+AnxD groups only).
  • Inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug with nicotine accepted) dependence (AUD alone and AUD+AnxD groups only).
  • A minimum of a sixth-grade reading level.
  • Healthy controls, same criteria absent AUD and AnxD diagnosis of an alcohol and/or anxiety disorder
  • Lives within proximity to the Twin Cities (e.g., within about an hour's drive) or willing to drive to Fairview for the purpose of attending follow-up visits
  • Willingness to provide contact information to confirm follow-up appointments

排除标准

  • Lifetime history of psychosis or mania
  • Cognitive impairment, physical impairment, or chronic medical illness that precludes study participation
  • Primary PTSD as determined by qualifying assessment
  • Females currently pregnant
  • Exposure to antipsychotic medication for a total duration >16 weeks.
  • Prior head injury leading to >30 minutes of unconsciousness.
  • Cognitive impairment that impedes study participation.
  • Healthy controls with a history of any major medical or psychiatric disorders (e.g., schizophrenia, depression, heart disease, or stroke).
  • Suicide intent or attempt in the past 30 days
  • Cardiovascular health issues
  • Thyroid Disease
  • History of severe neurological illness such as chronic seizure disorder (e.g, epilepsy) or stroke
  • Brain tumor and/or implants in the skull cavity (e.g., plate in the skull)
  • Pacemaker

结局指标

主要结局

Relapse Severity

时间窗: 4-month follow-up

Relapse severity will consist of the number days drinking during the 4 months following treatment discharge.

Relapse Status

时间窗: 4-month follow-up

Relapse status will be assessed using a categorical measure of whether someone did vs did not drink (yes vs. no) during the 4 months following treatment discharge.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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