Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Department of Psychology, School of Social Sciences, University of Mannheim, Mannheim, Germany.
BMJ Open. 2022 Jun 30;12(6):e058645. doi: 10.1136/bmjopen-2021-058645.
Adverse childhood experiences (ACE) are common and may predispose affected individuals to various health problems, including alcohol use disorder (AUD). Although a relationship between ACE and AUD has been well-established, potential mechanisms that may underlie this relationship remain to be elucidated. The importance of these mechanisms with respect to relapse risk is of particular interest, given the clinical relevance of relapse in addictions. Thus, the aim of this study is to longitudinally assess the role of clinically relevant variables in the relationship between ACE and AUD, namely stress sensitivity, emotion processing, cue reactivity and cognitive functioning (response inhibition and working memory), in relation to relapse risk.
In this observational, longitudinal case-control study, 36 patients with AUD and heavy drinkers with varying degrees of ACE from a previous project (NCT03758053) as well as newly recruited participants from the same study population will be assessed. Besides measuring long-term relapse in AUD by re-examining these 36 previous participants after 2-2.5 years, factors contributing to short-term relapse will be examined by reassessing all participants on a 3-month follow-up. Furthermore, participants with no or mild ACE will be compared with participants with moderate to severe ACE to assess between-subject differences in risk factors for AUD. Questionnaires and interviews will thus be used to cover individuals' drinking behaviour and ACE. Emotion processing, stress sensitivity, cue reactivity and cognitive functioning will be assessed using task-based functional MRI (fMRI). Additionally, saliva cortisol and blood samples will be taken to measure hormonal stress response and to perform genome wide association analyses, respectively. The general linear model will be applied on the first level fMRI analyses, whereas for the second level analyses and analyses of behavioural data, t-tests, regression analyses, repeated-measures and one-way analysis of variances will be used.
This study has been approved by the ethics committee of the Medical Faculty Mannheim of Heidelberg University (ethics approval number: 2018-560N-MA with amendment from 29 June 2021). The findings of this study will be presented at conferences and published in peer-reviewed journals.
NCT05048758; Pre-results, clinicaltrials.gov.
不良的童年经历（ACE）很常见，可能使受影响的个体易患各种健康问题，包括酒精使用障碍（AUD）。虽然 ACE 与 AUD 之间的关系已经得到充分证实，但潜在的机制仍有待阐明。鉴于成瘾复发的临床相关性，这些机制对复发风险的重要性尤其值得关注。因此，本研究旨在纵向评估临床上相关变量在 ACE 与 AUD 之间关系中的作用，即应激敏感性、情绪处理、线索反应和认知功能（反应抑制和工作记忆）与复发风险的关系。
在这项观察性、纵向病例对照研究中，将来自先前项目（NCT03758053）的 36 名 AUD 患者和具有不同程度 ACE 的重度饮酒者以及来自同一研究人群的新招募参与者进行评估。除了通过在 2-2.5 年后重新检查这 36 名先前参与者来测量 AUD 的长期复发外，还将通过在 3 个月的随访中重新检查所有参与者来检查短期复发的促成因素。此外，将无或轻度 ACE 的参与者与中度至重度 ACE 的参与者进行比较，以评估 AUD 风险因素的个体间差异。问卷和访谈将用于涵盖个体的饮酒行为和 ACE。使用基于任务的功能磁共振成像（fMRI）评估情绪处理、应激敏感性、线索反应和认知功能。此外，将采集唾液皮质醇和血液样本，分别测量激素应激反应和进行全基因组关联分析。将应用广义线性模型进行第一级 fMRI 分析，而对于第二级分析和行为数据的分析，将使用 t 检验、回归分析、重复测量和单向方差分析。
本研究已获得海德堡大学曼海姆医学系伦理委员会的批准（伦理批准号：2018-560N-MA，于 2021 年 6 月 29 日修订）。本研究的结果将在会议上公布，并发表在同行评议的期刊上。
NCT05048758；预结果，clinicaltrials.gov。
