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临床试验/NCT04032587
NCT04032587已完成不适用

Modification of Pavlovian and Instrumental Learning in Human Addiction

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年10月1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
80
试验地点
2
主要终点
Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI)

研究概览

简要总结

The project aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders.

详细描述

Project C02 aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders. The investigators will examine non-treatment seeking subjects with alcohol use disorder (AUD; mild vs. moderate to heavy), and healthy controls with a focus on the impact of Pavlovian conditioned stimuli (context-related cues) on instrumental behavior (so-called Pavlovian-to-Instrumental transfer (PIT)) and whether the PIT effect can be systematically modified by manipulating the approach/ avoidance propensities of Pavlovian cues (work package (WP) 1). Concerning stress as a major modulator of cue reactivity in addiction, the investigators further plan to assess whether acute, active stress reduction modifies such PIT effects (i.e. decreasing transfer effects) as well as goal-directed vs. habitual behavior (i.e. strengthening goal-directed decisionmaking) (WP2). Lastly, this project aims at contributing to the understanding of the underlying neurobiological correlates of manipulation of approach/ avoidance propensities of Pavlovian cues and acute stress reduction by using functional magnetic resonance imaging (WP3) with a focus on amygdala-striatal activity (PIT) and frontostriatal processes (goaldirected decision-making).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 16-32 years, 33-49 years, and aged 50-65 years
  • Mild, moderate to heavy alcohol-use disorder (AUD) according to DSM-5 criteria (mild: 2-3 AUD criteria; moderate: 4-5 AUD criteria; heavy: 6 or more AUD criteria); not clinically requiring detoxification (as confirmed by an independent board-certified psychiatrist); AUD patients can have mild to moderate cannabis use disorder as well as tobacco use disorder
  • Ability to provide fully informed consent and to use self-rating scales
  • Willingness to use an android phone
  • Sufficient understanding of the German language

排除标准

  • Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence. Severe alcohol and cannabis use disorder will be excluded.
  • Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
  • History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
  • Pregnancy or nursing infants
  • Current use of medications or drugs known to interact with the CNS within at least four half-life post last intake

结局指标

主要结局

Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI)

时间窗: 2 consecutive days

Rate of goal-directed decision-making/habitual decision making

时间窗: 2 consecutive days

Rate of Pavlovian-to-instrumental-Transfer (instrumental responding, i.e.number of button presses, in dependence of Pavlovian Stimuli)

时间窗: 2 consecutive days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Beck

Dr. rer. medic. Dipl.-Psych.

Charite University, Berlin, Germany

研究点 (2)

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