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临床试验/NCT02196142
NCT02196142已完成3 期

Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Change from baseline in alcohol craving score

研究概览

简要总结

To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects.

Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication.

Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.

详细描述

Background

Alcohol dependence is a chronically and relapsing disorder with major impact on the persons psychological, physiological and social functioning. There is extensive evidence from animal and human studies pointing out the important role of addiction memory in the development and maintenance of the disorder.

Cognitive behavioural therapy (CBT) has proven its high effectiveness in the treatment for addictive disorders. A core element of CBT are exposure techniques that are comparable to extinction and habituation learning. The repeated exposure to alcohol related cues in the absence of alcohol ingestion will lead to extinction of conditioned responses, thus reducing the probability of relapse to alcohol taking behaviour.

Studies have shown that glucocorticoids impair memory retrieval in healthy subjects. In fact, the investigators could show that cortisol has a fear reducing effect in patients with post-traumatic stress disorder and in phobic patients, resulting particularly in reduced symptoms of anxiety and in reduced stress reactivity. Interestingly enough, pharmacologically induced high levels of glucocorticoids lowered the subjective feeling of anxiety and stress in situations activating per se the HPA-axis. Further it has been shown that the combined therapy of glucocorticoid administration and exposition based psychotherapy leads to better therapy outcome in patients with specific phobias.

Objective

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Abstinent alcoholics in the 12-week in-patient program of the Clinic Südhang
  • Abstained from alcohol for at least 6 weeks
  • Voluntarily signed informed consent
  • Exclusion Criteria
  • Co-morbid psychiatric disturbances (such as major depression, bipolar disorder, schizophrenia)
  • Current medical conditions excluding participation (such as acute infectious disease)
  • Recent history of systemic or topic glucocorticoid therapy
  • Known hypersensitivity to the IMP under investigation (cortisol)
  • Pregnancy, breast-feeding
  • Inability to read and understand the participant's information
  • Positive alcohol test according to breathalyser

排除标准

  • 未提供

研究组 & 干预措施

Cortisol first, Placebo second

Active Comparator

Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)

干预措施: Cortisol 20mg (Drug)

Cortisol first, Placebo second

Active Comparator

Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)

干预措施: Placebo Mannitol (Drug)

Placebo first, Cortisol second

Active Comparator

Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)

干预措施: Cortisol 20mg (Drug)

Placebo first, Cortisol second

Active Comparator

Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)

干预措施: Placebo Mannitol (Drug)

结局指标

主要结局

Change from baseline in alcohol craving score

时间窗: During and after presentation of drug stimuli, expected to be after 10 minutes

Measured by Alcohol Urge Questionnaire \& Visual Analogue Scale

次要结局

  • Saliva Cortisol Level(After presentation of drug stimuli, expected to be after 90 minutes)
  • Change from baseline in heart rate variability(During and after presentation of drug stimuli, expected to be after 10 minutes)
  • Change from baseline in State-Trait-Anger Expression Inventory STAXI(After presentation of drug stimuli, expected to be after 20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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