Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Image based cue reactivity task
研究概览
简要总结
The study aims to utilise olfactory stimulation in addition to the visual stimulation in cue reactivity tasks to enhance precision in measuring alcohol based cues in individuals diagnosed with heavy drinking. The study consists of one cue reactivity task with visual stimuli, another cue reactivity task with matching odour/visual stimuli and lastly a monetary incentive delay task.
详细描述
The intention of the study is to enhance the measurement precision in image-based cue reactivity task by introducing a new level of stimuli in the form of odours. During the course of the functional Magnetic Resonance Imaging (fMRI) screening, participants are required to finish three tasks, namely; odour-based cue reactivity task (OCRT), image-based cue reactivity task(ICRT) and monetary incentive delay task (MID).
Participants will be randomly divided into two groups, one group will receive tasks in the following order: OCRT-MID-ICRT and the other group will receive them in the following order: ICRT-MID-OCRT. With this, the habituation effect from receiving odours during OCRT is expected to be balanced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 否
入选标准
- •An Heavy Drinking diagnosis, confirmed by Alcohol Use Disorders Identification Test
- •Ability to provide fully informed consent and to use self-rating scales in fMRI
- •Understanding of the German language
排除标准
- •Severe mental or physical illnesses
- •Any metal parts and pieces in the body
- •Claustrophobia; fear of confined spaces
结局指标
主要结局
Image based cue reactivity task
时间窗: Once during the fMRI screening
A cue reactivity task based on the images of alcoholic and non-alcoholic items. Adapted from Vollstädt-Klein et al., 2011. Subjects are presented with images of the alcoholic (beer, wine, schnapps) and the non-alcoholic (broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent) items during an fMRI session in blocks. In each block there are 5 images from the same stimuli group. After each block subjects are asked to rate their liking and wanting towards the items that have been presented to them in two 1-5 scales. Blocks are pseudorandomised to maximise balance between groups and minimise the effect of habituation. Minimum 1: "not at all", maximum 5: "very much".
Monetary incentive delay task
时间窗: Once during the fMRI screening
A task to invoke reward based activations in the subjects. Adapted from Kirsch et al., 2003. Subjects are presented 3 different stimulus conditions, each linked either to a positive monetary reward (a vertically oriented arrow pointing upward), a positive verbal feedback (a vertically oriented double-sided arrow) or a neutral no reward or feedback (a horizontally oriented double-sided arrow). After presentation of the two positive stimuli types, a flashing screen is presented and during the flashing screen if the subjects can press the button fast enough they will either win 1€ or they will be shown a positive verbal feedback depending on the positive stimuli type. The negative stimuli is followed by a 3 second black screen to include a control condition. Each stimulus condition is presented 10 times in a pseudorandom schedule with no more than two equal conditions in succession. The inter-trial interval randomly varies between 6-9 seconds.
Odour based cue reactivity task
时间窗: Once during the fMRI screening
A cue reactivity task based on the odours and images of alcoholic and non-alcoholic items. Adapted from Vollstädt-Klein et al., 2011. Subjects are presented with odours and images of alcoholic (beer, wine, schnapps) and non-alcoholic (odour: 2-Methyltetrahydrofuran-3-one / images: broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent) items during an fMRI session in blocks. For non-alcoholic items, in each block 5 images from the same stimuli group are presented with the non-alcoholic odour. For alcoholic items, in each block there are 5 images from the selected stimuli group with the congruent odour. After each block subjects are asked to rate their liking and wanting towards the items that have been presented to them in two 1-5 scales. Blocks are pseudorandomised to maximise balance between groups and minimise the effect of habituation. Minimum 1: "not at all", maximum 5: "very much".
Change in Blood Oxygen Level Dependent (BOLD) signal within selected Regions of Interest (ROI)
时间窗: Once during the fMRI experiment
Change in brain activation in the form of BOLD signals within 3 groups of ROIs: * Memory related ROIs: Hippocampus, Dorsolateral Prefrontal Cortex * Cognitive Control related ROIs: Anterior Cingulate Cortex, Ventrolateral Prefrontal Cortex * Reward related ROIs: Striatum (ventral and dorsal) and Insula
次要结局
- Stanford Sleepiness Scale (Hoddes et al. 1973)(Once before the fMRI screening)
- Alcohol Urge Questionnaire (Bohn et al. 1995)(Once before the fMRI screening)
- Psychomotor Vigilance Test (Roach et al. 2006)(Once before the fMRI screening)
- Sniffin' Sticks Test (Burghardt®, Wedel, Germany)(Hummel et al., 1997)(Once before the fMRI screening)