A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
详细描述
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 21-75;
- •current diagnosis of compulsive sexual behavior
排除标准
- •unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
- •history of seizures;
- •myocardial infarction within 6 months;
- •current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- •clinically significant suicidality;
- •current or recent (past 1 month) DSM-IV substance abuse or dependence;
- •illegal substance within 2 weeks of study initiation;
- •initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
- •initiation of a psychotropic medication within 2 months prior to study inclusion;
- •previous treatment with naltrexone; and
- •treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
研究组 & 干预措施
Naltrexone
Naltrexone 50mg-150mg by mouth per day.
干预措施: Naltrexone (Drug)
Placebo
Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
干预措施: Sugar pill (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
时间窗: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).
次要结局
- Clinical Global Impression Scale - Severity(Assessed at each visit (every two weeks) until participation in the study was done (Week 8))