A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- National Institute of Mental Health Trichotillomania Symptom Severity Scale
研究概览
简要总结
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
详细描述
The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 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 18-75;
- •current DSM-IV trichotillomania;
- •hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
排除标准
- •unstable medical illness or clinically significant abnormalities on pre-study 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 3 months) 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 for the treatment of trichotillomania 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;
- •lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- •current use of opiates.
研究组 & 干预措施
1
Naltrexone
干预措施: Naltrexone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
National Institute of Mental Health Trichotillomania Symptom Severity Scale
时间窗: This is the final score, measured at week 8 (final visit).
Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.
次要结局
- Massachusetts General Hospital Hairpulling Scale(This is the final score, measured at week 8 (final visit).)
- Liver Function Tests(Week 8 (last visit))