Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Score on AISRS From Baseline to Week 6
研究概览
简要总结
The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Naltrexone
Arm 1: Naltrexone + SODAS MPH
干预措施: Naltrexone (Drug)
Naltrexone
Arm 1: Naltrexone + SODAS MPH
干预措施: SODAS MPH (Drug)
Placebo
Arm 2: Placebo + SODAS MPH
干预措施: SODAS MPH (Drug)
结局指标
主要结局
Change in Score on AISRS From Baseline to Week 6
时间窗: Baseline and 6 Weeks
The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.
Safety
时间窗: 6 Weeks
Number of adverse events throughout the course of the study
次要结局
未报告次要终点
研究者
Thomas J. Spencer, MD
Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology
Massachusetts General Hospital