Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 12
- 主要终点
- ADHD Severity
研究概览
简要总结
The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.
详细描述
Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for ADHD
- •Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder
- •Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed checklist
排除标准
- •Serious medical illness
- •History of tic disorder
- •Pregnant or breastfeeding
- •Meet DSM-IV criteria for current or life-time psychotic disorder
- •Meet DSM-IV criteria for current or life-time bipolar disorder
- •Requires/or prescribed other concurrent psychotropic medication
- •Taking any medications that may produce interactions with OROS-MPH
- •Opiate dependence
- •Methamphetamine abuse or dependence
- •Suicidal risk
- •Enrolled in an inpatient, residential, day treatment, or outpatient substance abuse program within 28 days prior to signing consent
研究组 & 干预措施
Methylphenidate
干预措施: Methylphenidate (OROS-MPH) (Drug)
Methylphenidate (Placebo)
干预措施: Methylphenidate (OROS-MPH) - Placebo (Drug)
结局指标
主要结局
ADHD Severity
时间窗: baseline and 20 weeks
DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.
Substance Use
时间窗: 20 weeks
The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.
次要结局
- OROS-MPH Abuse Liability(20 weeks)
- Substance Use Outcomes(20 weeks)
研究者
Theresa Winhusen
Associate Professor
University of Cincinnati