Naltrexone: Consummatory Behaviors in Alcoholic Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Time to first day of heavy drinking
研究概览
简要总结
This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.
详细描述
Background: Despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid eating pathology.
Methods: One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days.
- •Able to read English and complete study evaluations.
- •A stable residence and a telephone to ensure that subjects can be located during the study.
排除标准
- •Meets criteria for dependence on another psychoactive substance besides alcohol or nicotine.
- •Regular use of psychoactive drugs except antidepressants.
- •Current use of disulfiram (Antabuse).
- •Psychotic or otherwise severely psychiatrically disabled.
- •Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology.
- •Abstinent longer than 30 days prior to admission to program.
- •Hepatocellular disease or elevated bilirubin levels.
- •Individuals with present history of opiate abuse or who require the use of opioid analgesics.
- •Women who are pregnant, nursing, or not using a reliable method of birth control.
- •Women who are significantly overweight or significantly underweight.
研究组 & 干预措施
Placebo
Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks.
干预措施: Placebo (Drug)
Naltrexone
Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks.
干预措施: naltrexone (Drug)
结局指标
主要结局
Time to first day of heavy drinking
时间窗: 12 weeks
Defined as consuming 4 or more drinks during the 12-week period
Time to first day of drinking
时间窗: 12 week treatment period
次要结局
- Percentage of days abstinent(12 weeks of treatment)
- Percentage of heavy drinking days(12 weeks of treatment)
- Beck Depression Index(12 weeks of treatment)
- Obsessive Compulsive Drinking Scale (OCDS)(Baseline, Month 1, 2, 3)
- Eating Disorder Examination (EDE)(baseline, month 1, 2, 3)