Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Symptoms of ADHD and SUD (measured at Week 12)
研究概览
简要总结
Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.
详细描述
High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD is a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor, and is currently used to treat adolescents with ADHD. The purpose of this trial is to evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.
This study will last up to 18 weeks. Participants will receive six treatments of manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks. Participants and their parents will partake in therapy sessions. Subjects who have completed at least 2 weeks of CBT will be eligible to enter the controlled trial, at which point participants will be randomly assigned to receive either atomoxetine or placebo, which they will take once daily for 12 weeks. At the Week 12 study visit, participants will be assessed for symptoms of ADHD and SUD.
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
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of ADHD
- •Current or recent (within the three months prior to study entry) SUD, including marijuana and alcohol abuse
- •ADHD CGI-S score of greater to or equal to 4
排除标准
- •Any Unstable medical condition
- •Recent history of intravenous drug use or cocaine dependence
- •Currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine, amphetamine, opioids, phencyclidine, or benzodiazepine
- •Mental retardation or organic brain syndrome
- •Currently psychotic or history of bipolar disorder
- •Currently taking any psychotropic or anti-substance abuse disorder medications
- •Current DSM-IV diagnosis of major depression, depressive disorder, or anorexia
- •Pregnant or breastfeeding
研究组 & 干预措施
1
Treatment with placebo or atomoxetine for 12 weeks.
干预措施: Placebo (Drug)
2
干预措施: Atomoxetine hydrochloride (Drug)
结局指标
主要结局
Symptoms of ADHD and SUD (measured at Week 12)
时间窗: 12 Weeks (LOCF)
次要结局
未报告次要终点
研究者
Timothy Wilens, MD
MD
Massachusetts General Hospital