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临床试验/NCT02181608
NCT02181608撤回不适用

Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics

National Institute on Alcohol Abuse and Alcoholism (NIAAA)0 个研究点开始时间: 2014年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
To compare physiological and neural outcomes in treatment-seeking alcoholics across multiple challenge procedures as a function of early life stress (ELS) exposure.

研究概览

简要总结

Background:

  • Researchers want to see if people with alcohol dependence have more trouble learning to feel calm, or learn to fear things more easily, than non-alcoholics and to study how early life stress (ELS) affects these things.

Objective:

  • To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these conditions.

Eligibility:

  • Adults age 21 65 with diagnosed alcohol dependence, with/without ELS.
  • Healthy volunteers age 21 65 with/without ELS.

Design:

  • All participants will be screened with medical history and physical exam. They will have blood and urine tests, and a psychological assessment.
  • Participants with alcohol dependence will:
  • be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls and 3 in-person visits over 3 months.
  • follow the NIH alcohol treatment program during the study. They cannot take psychiatric medications.
  • rate their alcohol craving, depression, and anxiety throughout the study.
  • have fear conditioning and extinction sessions that use noise and mild electric shock. Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine that takes images, while they perform tasks.
  • listen to recordings that describe stressful events. They will rate their feelings and have blood drawn through an intravenous (IV) line.
  • have their hormone response to stress tested. They will take a pill and get a hormone via an IV, then have blood drawn.
  • Healthy volunteers will:
  • have 2 inpatient stays, each lasting a few days. They will answer questions about how they feel.
  • have fear conditioning and extinction sessions, including fMRI.
  • have blood drawn several times.

详细描述

Objective:

The primary objective of the study is to evaluate the role of early life stress (ELS), alcohol dependence (AD), and their interaction in psychophysiology and neural mechanisms of fear conditioning and extinction.

The main outcome of interest is fear extinction, as measured by laboratory-based and fMRI paradigms. Secondary objectives of the study include: (1) explore the impact of early life stress on behavioral and endocrine response to challenge procedures among individuals with AD; (2) explore differences in reward processing, emotion processing, and neural response to alcohol beverages as measured by fMRI as a function of AD and ELS; and (3) examine the relationship between fear extinction and clinical outcomes in our patient sample.

Study Population:

The study sample includes four groups: 1) treatment-seeking individuals with alcohol dependence (AD) and ELS exposure; 2) treatment seeking individuals with alcohol dependence without ELS exposure; 3) healthy social drinkers without alcohol use disorders (AUD) but with ELS exposure; and 4) healthy social drinkers without AUD and without ELS exposure. Target accrual for each of these groups is 25.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To compare physiological and neural outcomes in treatment-seeking alcoholics across multiple challenge procedures as a function of early life stress (ELS) exposure.

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
申办方类型
Nih
责任方
Sponsor

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