NCT01548417已完成2 期
Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Craving to Drink
研究概览
简要总结
The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female volunteers, 18-65 years of age
- •Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Addition (DSM-IV) criteria for current alcohol dependence
- •Subjects will not be seeking treatment because the medication studies are not treatment trials
- •Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
- •Negative Breath Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment-Alcohol (CIWA-A) score of < 8 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures
- •Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent
排除标准
- •Significant medical disorders that will increase potential risk or interfere with study participation as determined by the Study Physician
- •Female subjects with childbearing potential who are pregnant, nursing, or refuse to use double barrier (non-hormonal) methods of birth control for the duration of the study and one month thereafter
- •Meets DSM-IV criteria for a major Axis I disorder including mood or anxiety disorders or substance dependence disorders other than alcohol or nicotine dependence
- •History of allergy or hypersensitivity to the study drugs or the ingredients
- •Treatment within the month prior to screening with 1.) an investigational drug or vaccine; 2.) drugs that may influence study outcomes, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), anticonvulsants, antidepressants.
- •In need of or currently taking any psychoactive medications.
研究组 & 干预措施
Korlym (mifepristone)
Active Comparator
600 mg daily taken orally for one week
干预措施: Korlym (mifepristone) (Drug)
Sugar Pill
Placebo Comparator
placebo pill daily taken orally for one week
干预措施: Sugar Pill (Drug)
结局指标
主要结局
Craving to Drink
时间窗: 1 week
Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
次要结局
- Drinking(2 weeks)
研究者
Barbara J. Mason
PI
The Scripps Research Institute
研究点 (1)
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