An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Percent Heavy Drinking Days
研究概览
简要总结
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will meet criteria for primary alcohol dependence operationalized as follows:
- •A. Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification
- •Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
- •Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
- •Able to read and understand questionnaires and informed consent
- •Lives within approximately 50 miles of the study site -
排除标准
- •Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
- •Ever abused opiates
- •Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
- •Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
- •Meets DSM IV current criteria for dissociative disorder or eating disorders
- •Has current suicidal ideation or homicidal ideation
- •Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
- •Current use of disulfiram
- •Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
- •Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
- •Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not using a reliable form of birth control
- •Has current charges pending for a violent crime (not including DUI-related offenses)
- •Does not have a stable living situation and a reliable source of collateral reporting
- •Has taken an opiate antagonist drug in the last month
- •Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
Naltrexone
干预措施: Naltrexone (Drug)
3
Naltrexone + Aripiprazole
干预措施: Naltrexone + Aripiprazole (Drug)
结局指标
主要结局
Percent Heavy Drinking Days
时间窗: 16 weeks
percent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)
Drinks Per Drinking Day
时间窗: 16-week treatment period
Standard drinks per drinking day
次要结局
- Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance(16 weeks treatment trial)
- Pill Counts During Treatment(16-week)
研究者
Raymond F. Anton
Distringuished University Professor
Medical University of South Carolina