A Randomized, Placebo-controlled Trial of Atomoxetine for Attention Deficit Hyperactivity Disorder in Adolescents With Substance Use Disorder (SUD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
研究概览
简要总结
The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.
详细描述
Evidence-based psychosocial treatments have recently been developed. However, very little data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common co-occurring disorder in adolescent SUD is attention-deficit/hyperactivity disorder (ADHD). Fortunately, new ADHD medications, such as atomoxetine, that do not have addictive potential are now available. However, all controlled studies of atomoxetine have specifically excluded teens with SUD. Therefore, little data exist on the safety and efficacy of the medication in this population. This research project will address the important research gap with the specific aim: to conduct a randomized, placebo-controlled trial of atomoxetine for ADHD in teens with 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
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12-19
- •Provided assent/consent
- •attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
- •Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist <=22
- •At least one non-nicotine substance use disorder (SUD) by KSADS
- •Plans to live locally for 4 months
- •Willing to participate in cognitive behavioral therapy (CBT)
排除标准
- •No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
- •No allergy to atomoxetine
- •No narrow angle glaucoma
- •No serious medical illness
- •Not pregnant
- •Not unwilling to use an effective form of contraception during the trial
- •No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication
研究组 & 干预措施
1
placebo plus individual cognitive behavioral therapy
干预措施: Placebo (Drug)
2
atomoxetine plus individual cognitive behavioral therapy
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist
时间窗: baseline and weekly through week 12 post randomization
All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.
次要结局
- Time Line Followback Interview (TLFB)(12 weeks)
- Side Effect Form for Children and Adolescents (SEFCA)(weekly from randomization to 12 weeks post-randomization)