Glucocorticoid Antagonist Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Drinking Quantity Per Day
研究概览
简要总结
This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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 (DSM)-V criteria for current alcohol use disorder of moderate or greater severity, defined by DSM-V as ≥ 4 symptoms
- •Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
- •In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
- •Females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter
排除标准
- •A medical condition or chronic use of a medication that contraindicates the administration of mifepristone
- •Significant medical disorders or clinically significant findings on ECG (e.g., prolongation of the corrected QT interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician. Note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized
- •Liver function tests more than 3 times the upper limit of normal or elevated bilirubin
- •Female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter
- •Meets Diagnostic and Statistical Manual -V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders
研究组 & 干预措施
Experimental: mifepristone 1200 mg daily
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
干预措施: Mifepristone 1200 mg daily (Drug)
Experimental: mifepristone 1200 mg daily
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
干预措施: Standardized behavioral therapy (Behavioral)
Placebo daily, 1-week
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
干预措施: Standardized behavioral therapy (Behavioral)
Placebo daily, 1-week
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Drinking Quantity Per Day
时间窗: Participants will be followed for up to 12 weeks post-assignment
Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.
次要结局
- Craving(Participants will be followed for up to 12 weeks)