Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence
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
- 否
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
Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)
干预措施: Cortisol 20mg (Drug)
Cortisol first, Placebo second
Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)
干预措施: Placebo Mannitol (Drug)
Placebo first, Cortisol second
Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)
干预措施: Cortisol 20mg (Drug)
Placebo first, Cortisol second
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)
