跳至主要内容
临床试验/NCT06701500
NCT06701500招募中不适用

SFB TRR 265: Losing and Regaining Control Over Drug Intake Project B03: Role of Pavlovian Mechanisms for Control Over Substance Use Project B09: Maladaptive Context Inference As Key Mechanism Underlying Impaired Control

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Behavioral single-lever Pavlovian to instrumental transfer (PIT) effect

研究概览

简要总结

The first aim of this study is to establish the role of maladaptive reliance on habits for impaired control in addiction, employing a novel task - the Action-Sequence-Task (AST), which assesses interference between habitual and goal-directed control. The AST, along with the developed computational model, will be employed to test whether participants with Alcohol Use Disorder (AUD) and control participants differ with respect to task performance and estimated model parameters. The investigators hypothesize stronger habitual behavior (increased habitual tendency) and an increased susceptibility to conflict between habitual and goal-directed control, measured as increased interference, are associated with AUD.

The second aim of the study is to understand whether Pavlovian-to-Instrumental Transfer (PIT) reflects more of a controlled, goal-directed process, or a more automatic, habitual process. The investigators will use the single-lever PIT task as it is an efficient tool for testing the interaction between Pavlovian cues and instrumental behavior, especially when they are in conflict. In these trials, top-down control must be allocated to successfully overcome the conflict, which may share some common underlying mechanisms with the arbitration between goal-directed and habitual behavior during conflict, as assessed by the novel AST. The third aim of the study is to investigate whether severely dependent AUD patients would show a stronger PIT effect compared to a control group, consistent with the investigators' previous findings.

详细描述

This project has three research aims:

  1. Investigate whether stronger habitual behavior and increased susceptibility to the conflict between habitual and goal-directed control are associated with SUD
  2. Investigate whether PIT is more of a habitual or a goal-directed process.
  3. Replicate the previous findings that moderate to severely dependent AUD patients show a stronger PIT effect in contrast to the control group The experiment will be conducted in 90 AUD patients and 90 age and gender-matched controls. Participants will perform the AST task over two consecutive days, and during the second day, they will also perform the single-lever PIT task. In the AST, participants need to press four keys according to the cue location; two keys are associated with high reward, while the other two are associated with low reward in case of correct and timely responses. The explicit goal is to maximize the reward. While in half of the trials the cues are presented in a random order, in the other half of the trials, participants repeatedly perform a fixed action sequence of 12 elements (habit condition). The degree of action sequence chunking (i.e. automation) is assessed via the differences in error rates and reaction times between the random and fixed order condition (habit parameter). Importantly, 15% of all trials are dual- target trials. In these, the goal-directed system (press high reward key) and the action sequence (press sequence key) can either be in line (congruent trials) or in conflict (incongruent trials) with each other. Thus, the interference between goal-directed and habitual control can be tested.

The single-lever PIT task consists of four phases. In the instrumental task, participants need to learn which shells to collect or leave in order to gain as much money as possible; the correct choice is probabilistically rewarded in 80% of all times. During the Pavlovian conditioning phase, colorful fractals are presented in the back of the screen, which have been passively paired either with monetary loss, no change or monetary gain, i.e. they act as positively valued, neutral or negatively valued cues. During the transfer phase, participants were instructed to perform the instrumental task as they have done previously. These fractals thus act as independent, Pavlovian conditioned background stimuli and interact with instrumental behavior in the unrelated task to collect the correct shells. To avoid further learning, this transfer part will be conducted under nominal extinction. Finally, query trials, in which one of two pictures will have to be chosen, will be used to assess the relative cue value.

The participants will additionally perform a Counting Stroop task and a No-go Simon task. In the Stroop task, either one, two, three or four identical digits from 1 to 4 are shown. Number and denotation of digits are either congruent (1, 22, 333, 4444; 80 trials) or incongruent (111, 2222, 3, 44; 80 trials). Subjects have to indicate how many digits were shown. In the No-go Simon task, the investigators will show arrows either pointing to the left or right. The arrow can either be shown on the left or the right side of the display. In congruent trials, direction and position are the same, whereas they differ in incongruent trials. Participants have to indicate the direction of the arrow and ignore the position. 20% of trials are No-go trials, indicated by bold arrows. Here subjects have to always withhold a response (inhibition task).

Expected results:

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

入选标准

  • 18-65 years of age
  • AUD subjects only: meet 4 or more criteria for DSM-5 alcohol use disorder
  • Sufficient motor skills and visual acuity to use PC
  • Ability to consent to the study and complete the questionnaires
  • Sufficient German skills

排除标准

  • Lifetime diagnosis of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder
  • Current diagnosis of severe major depression according to DSM-5, or presence of suicidal intention
  • Pregnancy
  • Severe withdrawal symptoms
  • Acute drug intoxication at the appointments

结局指标

主要结局

Behavioral single-lever Pavlovian to instrumental transfer (PIT) effect

时间窗: 1 day, 1 hour

Strength of interference PIT effect assessed with the single-lever PIT paradigm: increased error rate in the incongruent condition as compared with the congruent condition.

Action Sequence Task (AST) day one and day two

时间窗: 2 days, 1 hour per day

Habit formation: faster response time and decreased errors of preforming fixed compared to the random action sequence. Shift from goal-directed to habitual control: less choices of the high reward keys in trials in the incongruent trials where the goal-directed control and the habitual action sequence are in conflict (incongruent trials)

次要结局

  • Counting Stroop task(1 day, 10 minutes)
  • Go-Nogo Simon task(1 day, 20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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