Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Self-reported Weekly Substance Use
研究概览
简要总结
The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients 18 years old or older, up to 60 years old.
- •Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
- •Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)
排除标准
- •Any clinically unstable medical condition
- •Clinically significant abnormal baseline laboratory values
- •Mental retardation (I.Q. <75) or Organic brain disorders
- •Seizure disorder
- •Patients with a history or an eating disorder including anorexia or bulimia nervosa
- •Pregnant or nursing females
- •Patients with current bipolar disorder
- •Psychotic disorder of any type
- •Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)
- •Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)
- •Patients demonstrating active withdrawal from substance abuse
研究组 & 干预措施
Bupropion
干预措施: Bupropion SR (Drug)
结局指标
主要结局
Self-reported Weekly Substance Use
时间窗: baseline and six weeks
Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
时间窗: baseline and six weeks
Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)
次要结局
- Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity(baseline and six weeks)
- Clinical Global Impressions (CGI) Scale of ADHD Severity(baseline and six weeks)
- Hamilton Anxiety Scale (HAM-A)(baseline and six weeks)
- Hamilton Depression Scale (HAM-D)(baseline and six weeks)
- Beck Depression Inventory (BDI)(baseline and six weeks)
研究者
Timothy Wilens, MD
MD
Massachusetts General Hospital