Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in fMRI Measure
研究概览
简要总结
Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk.
However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General: pre-pubertal (e.g. Tanner stage 1 or 2)
- •age 7-12 inclusive
- •signed consent/assent
- •parent communicates sufficiently in English
- •Has ADHD as determined by parent interview
- •ADHD-Rating Scale-5 total score (interview with parent) of 1.5 SD > age/sex norms
- •Youth with CD or severe ODD: CD or ODD + 2 symptoms of CD
排除标准
- •major neurological/medical illness
- •history of head injury
- •fetal exposure to alcohol/drugs;
- •diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder) current suicidal ideation or past history of suicide attempt
- •Wechsler Abbreviated Scale of Intelligence (WASI) score <75; 7)
- •current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline; youth who had a past, brief stimulant medication exposure of no more than about a month, and not within the past 6 months may be included .)
- •current or past alcohol/drug use (interview; urine toxicology)
- •psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity)
- •metal in the body that cannot be removed
- •visual disturbances that may impair task performance
- •precocious puberty (e.g. Tanner stage >2).
研究组 & 干预措施
Adderall
dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth
干预措施: Adderall (Drug)
结局指标
主要结局
Change in fMRI Measure
时间窗: baseline and 3 weeks post intervention
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).
次要结局
- Change in Clinical Global Impression - Improvement (CGI-I)(baseline and post treatment, average 2 weeks)
- ADHD Rating Score (ADHD RS)(Pretreatment, baseline and Post-Treatment, average 2 weeks)
- Total Dose of MAS-XR(average 2 weeks)
研究者
Jeffrey Newcorn
Professor
Icahn School of Medicine at Mount Sinai