Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health (CIMH), Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany.
Trials. 2022 Aug 19;23(1):693. doi: 10.1186/s13063-022-06626-w.
Multiple studies indicate that a lower plasma level of the acetylated form of the appetite-regulating hormone ghrelin and higher plasma levels of insulin lead to a reduction in subjective alcohol craving and a reduced mesolimbic cue reactivity in functional magnetic resonance imaging (fMRI) when being exposed to alcohol-associated stimuli. The ghrelin level can physiologically be reduced by the induction of stomach distension and the ingestion of glucose or lipids.
A total of 108 alcohol-dependent patients aged between 18 and 65 years are examined in the randomized, double-blind, placebo-controlled crossover study. After collecting demographic and psychometric data, participants take part in an alcohol exposure session. Afterwards, the participants go through the intervention condition (oral glucose intake) and the control condition (placebo intake) in a randomized order on two examination days. Blood samples are taken repeatedly (every 10 min) during the study course on both measuring days to determine changes in acetylated and total ghrelin and insulin plasma levels. In parallel, subjective alcohol craving after the glucose or placebo intake as the primary outcome is assessed using the Alcohol Urge Questionnaire (AUQ) and a visual analog scale (VAS). To examine the mesolimbic cue reactivity as the secondary outcome, a fMRI measurement is conducted while being exposed to alcohol-related stimuli. Appropriate statistical analysis will be used for the evaluation of the outcomes.
If successful, the results of this study could offer alcohol-dependent patients a new potential option for acute short-term reduction of alcohol craving and thus prevent relapses and prolong periods of abstinence in the long term.
German Clinical Trials Register DRKS00022419 (UTN: U1111-1278-9428). Retrospectively registered on September 15, 2020.
多项研究表明，降低食欲调节激素 ghrelin 的乙酰化形式的血浆水平和升高胰岛素的血浆水平，在接触酒精相关刺激时，会导致主观的酒精渴求减少和中脑边缘线索反应性降低，这种作用在功能磁共振成像（fMRI）中可以观察到。ghrelin 的水平可以通过诱导胃部扩张和摄入葡萄糖或脂肪来生理降低。
这项随机、双盲、安慰剂对照的交叉研究共纳入了 108 名年龄在 18 至 65 岁之间的酒精依赖患者。在收集人口统计学和心理测量数据后，参与者参加了酒精暴露疗程。之后，参与者在两天的检查中按随机顺序分别接受干预条件（口服葡萄糖摄入）和对照条件（安慰剂摄入）。在研究过程中，在两次测量日中，每隔 10 分钟重复采集血液样本，以确定乙酰化和总 ghrelin 和胰岛素的血浆水平变化。同时，使用酒精渴求问卷（AUQ）和视觉模拟量表（VAS）评估葡萄糖或安慰剂摄入后的主观酒精渴求，作为主要结局。为了检测中脑边缘线索反应性，作为次要结局，在暴露于酒精相关刺激时进行 fMRI 测量。将使用适当的统计分析来评估结果。
如果成功，这项研究的结果可能为酒精依赖患者提供一种新的潜在选择，用于急性短期降低酒精渴求，从而预防复发并延长长期戒酒期。
德国临床试验注册处 DRKS00022419（UTN：U1111-1278-9428）。于 2020 年 9 月 15 日回顾性注册。
