Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in nicotine consumption from pre-intervention to post-intervention
研究概览
简要总结
This study investigates the mechanisms, through which physical exercise impacts positively on abstinence in tobacco use disorder, with fMRI and behavioral tests.
详细描述
This study will test the hypothesis that physical exercise training modifies alternative reward cue reactivity and cognitive control in tobacco use disorder and that these modifications mediate the effect of exercise on abstinence. Continued physical exercise training was shown to reduce tobacco consumption and prevent relapse in tobacco use disorder (TUD). However, the psychological and neural mechanisms through which exercise training exerts its effects on tobacco consumption are not clear. The aim of this project is to identify the effects of a 12-week aerobic exercise training in TUD and to test how these exercise-related changes may mediate the effect of exercise training on abstinence. Investigations will focus on two potential mechanisms of regaining control: (1) modifications of tobacco and alternative reward cue reactivity and (2) improvement of cognitive control. Two aspects of cognitive control will be addressed: inhibitory control and cognitive down-regulation of craving. It is expected, first, that exercise training (compared to standard treatment) leads to desensitization towards tobacco cues and sensitization towards alternative reward cues, reflected in altered craving and neural (fMRI) cue reactivity. Second, it is expected that exercise training will lead to increased cognitive control (i.e., inhibitory control and cognitive down-regulation of craving), reflected in increased activation of prefrontal control regions (fMRI). Third, it is expected that effects of exercise on abstinence will be mediated by sensitization towards alternative reward cues and enhanced cognitive control. In an exploratory manner, gender differences in the effects of exercise training will be studied. Understanding the psychological and neural underpinnings will help to optimize and individualize exercise trainings in TUD.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tobacco use disorder according to DSM-5
- •right-handedness
- •sufficient ability to communicate with investigators
- •ability to provide informed consent and to use self-rating scales
- •seeking treatment for TUD
- •no contra-indication for aerobic exercise
排除标准
- •severe internal or neurological comorbidities
- •axis I mental disorders other than TUD (except for mild depression, adjustment disorder and specific phobias) in the last 12 months according to DSM-5
- •history of brain injury
- •pregnancy
- •exclusion criteria for MRI
- •positive drug screening (opioids, benzodiazepines, cocaine, amphetamines)
- •psychotropic medication within the last 14 days
结局指标
主要结局
Change in nicotine consumption from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
self-report
Change in nicotine consumption from pre-intervention to follow-up
时间窗: Pre-intervention and follow-up (12 weeks after intervention end)
self-report
Change in BOLD during cue reactivity task (fMRI) from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Blood Oxygen Level Dependent especially within the ventral striatum, the ventral medial prefrontal cortex and the amygdala during a cue reactivity task with neutral, tobacco, alternative reward images and warning images depicting aversive consequences of smoking
Change in BOLD during down-regulation of craving task (fMRI) from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Blood Oxygen Level Dependent especially within the ventral striatum, the amygdala and the dorsolateral prefrontal cortex during a cognitive down-regulation of craving task with tobacco and alternative reward stimuli
Change in BOLD during stop-signal task (fMRI) from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Blood Oxygen Level Dependent especially within the dorsolateral prefrontal cortex during a stop signal task
Change in craving ratings (behavioral) from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
The participants' answers to the question "how strong is your desire to consume the item shown" on a scale of 1 - 8 is averaged over a total of 144 pictures of nicotine and alternative reward stimuli. The change in average ratings between pre-intervention and post-intervention is computed.
Change in down-regulation of craving (behavioral) from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
The down-regulation of craving task is carried out as described in Kober et al., 2010. As described there, the down-regulation of craving is calculated as the difference in craving ratings between the now and later condition (20 nicotine and alternative reward stimuli are shown in the now and later condition). The change in the down-regulation of craving between pre- and post-intervention is then calculated.
Change in stop-signal reaction time (behavioral) from pre-intervention to post-intervention
时间窗: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Stop-signal reaction time in the stop-signal task
次要结局
未报告次要终点
研究者
Prof. Dr. Andreas Ströhle
Principal Investigator
Charite University, Berlin, Germany