SFB TRR 265: Losing and Regaining Control Over Drug Intake B03: Role of Pavlovian Mechanisms for Control Over Substance Use WP2: Effects of Social Isolation on PIT in AUD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Behavioral full-lever specific and general PIT (parallel version) effect day one
研究概览
简要总结
During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study:
Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.
详细描述
The projects research aim:
The investigators will examine how an experimentally induced social exclusion by the Cyberball task is associated with alcohol specific and general PIT effects by using the newly developed full transfer task from 1st funding period in AUD vs. HCs.
The investigators will use the newly developed full PIT paradigm to examine the modifying effect of experimentally induced social exclusion stress on alcohol-specific and general PIT effects. While using the Trier Social Stress Test in the 1st FP, the investigators now want to go one step further by including social exclusion/ostracism to the stress component, which has not been studied in association with PIT effects yet. The investigators here want to shed light on possible underlying mechanisms which can lead to a promotion of alcohol-seeking by alcohol-stimuli in situations of social exclusion.
Participants (50 AUD and 50 HC) will be assessed at two time points, once after experimentally induced social exclusion and once after social inclusion in a fully balanced, cross-over within-subject design. Subjects will play an online game tossing a ball to each other with two more virtual co-players (Cyberball). Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Cyberball usually induces feelings of social isolation and altered behavioral reactions in the subject, which the investigators want to assess by analyzing ball tossing behavior over time, as well as physiological and subjective measures (concentration of cortisol in saliva, heart rate variability and emotions questionnaires, such as the Need to Belong Scale, Rejection Sensitivity Questionnaire, Need threat scale and Positive and Negative Affect Schedule pre and post Cyberball game and after PIT). After the Cyberball experiment, subjects will undergo the transfer part of the full PIT task (using a parallel version at one of the two days in a randomized order).
Hypothesis 1a:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Males and females between 18-65 years of age,
- •AUD subjects: meet 4 or more criteria for DSM-5 alcohol-use disorder (not requiring withdrawal as assessed by an independent psychiatrist),
- •Currently using alcohol without a desire for abstinence,
- •Ability to consent to the study and complete the questionnaires.
- •Sufficient language skills: German
- •Availability between 3pm-6pm on 2 consecutive days,
- •existing health insurance
排除标准
- •Lifetime diagnosis according to DMS-5 for a: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, cannabis, and/or methamphetamine
- •Currently meeting DSM-5 diagnostic criteria for depressive episode, suicidal ideation,
- •History of traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)
- •Pregnancy or breastfeeding,
- •Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test),
- •Color vision deficiency
结局指标
主要结局
Behavioral full-lever specific and general PIT (parallel version) effect day one
时间窗: Day 1
Specific: Average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol pavlovian background. General: Differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) pavlovian backgrounds.
Behavioral full-lever specific and general PIT (parallel version) effect day two
时间窗: Day 2
Specific: Average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol pavlovian background. General: Differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) pavlovian backgrounds.
Social exclusion/inclusion induced using Cyberball Game
时间窗: Day 2
experimentally-induced social exclusion stress by using the cyberball paradigm: Subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Effects of the Cyberball manipulation (social exclusion/inclusion) will be assessed via ratings in Positive and Negative Affect Scale (PANAS) and Need-Threat-Scale (NTS).
次要结局
- Positive and Negative Affect Schedule (PANAS)(Baseline and after Cyberball Experiment on Day 1 and Day 2)
- Need Threat Scale (NTS)(After Cyberball Experiment on Day 1 and Day 2)
- Concentration of cortisol in saliva(Day 1 and Day 2)
- Heart rate variability(At baseline 5 min AND During experimental part (social inclusion or exclusion) 5 min Day 1 and Day 2)
研究者
Andreas Heinz
Prof., MD, PhD
Charite University, Berlin, Germany