Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany,
Feuerlein Center on Translational Addiction Medicine, Heidelberg University, Heidelberg, Germany,
Eur Addict Res. 2021;27(5):332-340. doi: 10.1159/000512763. Epub 2021 Feb 10.
Preclinical studies have shown that calcium seems to be the active component of the anti-craving drug acamprosate (Ca2+ bis-acetyl-homotaurinate). Clinical effects in humans have also indicated an association between increased calcium plasma concentration due to acamprosate treatment and better outcome relating to time to relapse and cumulative abstinence. In contrast, low calcium concentration in alcohol-dependent patients was related with craving for alcohol. The main goal of the trial was to investigate whether an oral calcium administration is able to affect craving, withdrawal, and relapse risk in alcohol-dependent patients.
We conducted a single-blind, randomized, monocentric, controlled clinical two-arm trial in alcohol-dependent patients (Clinical Trials Registration: DRKS00011293). A total of 55 alcohol-dependent subjects received calcium carbonate (800 mg + 5 μg vitamin D) versus sodium bicarbonate (1,000 mg) daily during the 14 days of inpatient alcohol-withdrawal treatment.
Based on an intention-to-treat protocol, withdrawal intensity (assessed with CIWA-Ar) in the calcium carbonate group attenuated faster than in the sodium bicarbonate subgroup. Alcohol craving (assessed with OCDS) in the calcium carbonate subgroup was also significantly reduced versus the sodium bicarbonate subgroup.
Our data support earlier findings and show that treatment with calcium carbonate during alcohol withdrawal reduces symptoms of alcohol withdrawal as well as alcohol craving in a controlled clinical pilot study. Mode of actions will need to be determined to allow the further development of pharmacological interventions beyond Ca2+ bis-acetyl-homotaurinate.
临床前研究表明，钙似乎是抗渴求药物安米酮（Ca2+双乙酰高牛磺酸）的有效成分。人体临床效果也表明，由于安米酮治疗导致的血浆钙浓度增加与复发时间和累积戒断相关的更好结果之间存在关联。相比之下，酒精依赖患者的低钙浓度与对酒精的渴望有关。试验的主要目的是研究口服钙是否能够影响酒精依赖患者的渴求、戒断和复发风险。
我们在酒精依赖患者中进行了一项单盲、随机、单中心、对照的两臂临床试验（临床试验注册：DRKS00011293）。共有 55 名酒精依赖患者接受碳酸钙（800mg+5μg维生素 D）与碳酸氢钠（1000mg）每日治疗，为期 14 天的住院酒精戒断治疗。
根据意向治疗方案，碳酸钙组的戒断强度（用 CIWA-Ar 评估）比碳酸氢钠亚组更快减弱。碳酸钙亚组的酒精渴求（用 OCDS 评估）也明显低于碳酸氢钠亚组。
我们的数据支持早期发现，并表明在对照临床试验中，在酒精戒断期间使用碳酸钙治疗可减轻酒精戒断症状和酒精渴求。需要确定作用机制，以便在 Ca2+双乙酰高牛磺酸之外进一步开发药理学干预措施。
