Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)

Exclusion Criteria:

* Subjects who are known to not respond to methylphenidate
* Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components
* Have marked anxiety, tension or agitation
* Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder
B: Inclusion Criteria:

* Consent: The family must provide signature of informed consent by a parent or legal guardian. Children must also assent to study participation.
* Age at Screening:7.0 years to 11.9 years, inclusive.
* Sex: Includes male and female children.
* ADHD Diagnostic Status: Meets DSM-IV criteria for ADHD, Predominantly Inattentive or Combined subtype with Clinical Global Impression-Severity rating corresponding to at least "moderately ill."
* Cognitive Functioning-Intelligence Quotient (IQ) of greater than 80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children--4th Edition, or an Intelligence Quotient (IQ) of 80 or greater when administered the Full Scale Version of the Wechsler Intelligence Scale for Children-4th Edition.
* Absence of Learning Disability:On the abbreviated Wechsler Individual Achievement Test-2nd edition Reading and Math subtests, participants must score above 80. However, children may also be included if they receive a score of 75 or greater on the Word Reading and/or Math subtests, as long as this score is not a significant discrepancy from their full-scale IQ score (e.g., a difference of greater than one standard deviation or 15 points).
* School: Enrolled in a school setting rather than a home-school program.

Exclusion Criteria:

* Understanding Level: Participant and/or parent cannot understand or follow study instructions.
* Psychiatric Medications: Current or prior history of taking any medication for psychological or psychiatric problems.
* Behavioral Interventions: Current active participation in ADHD-related behavioral interventions or counseling.
* Exclusionary Psychiatric Conditions: Children with mania/hypomania and/or schizophrenia will be excluded. The following comorbid diagnoses will not be excluded unless they are determined to be the primary cause of ADHD symptomatology (see below for description of this decision process): Post Traumatic Stress Disorder, Phobias and Anxiety Disorders, Obsessive Compulsive Disorder, Major Depression / Dysthymia, Eating Disorders, Elimination Disorders, Trichotillomania, Tic Disorder, Oppositional Defiant Disorder, Conduct Disorder.
* Organic Brain Injury: History of head trauma, neurological disorder, or other organic disorder affecting brain function.
* Cardiovascular Risk Factors: Children with a personal history or family history of cardiovascular risk factors will be excluded, or given the option of participating in the study after obtaining an EKG and a signed letter from a pediatric cardiologist verifying the safety of their participation in a trial of methylphenidate. In this case, families will be responsible for the costs of EKG and cardiologist evaluation. If for any reason a family is unable to assume the cost of the EKG and cardiologist evaluations but still wishes for their child to participate, study staff will determine on a case-by-case basis whether the study budget allows the study to offer financial assistance to the families for these evaluations.
C: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
D: Inclusion Criteria:

* male and female volunteers
* 18-40 years old
* healthy
* body mass index between 5th and 85th percentile
* Caucasian
* non smoker or moderate smoker (\<10 cigarettes per day)
* able to understand, write, and read German

Exclusion Criteria:

* acute or chronic pain condition (except for mild day-to-day pain on \<5 days/month)
* previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
* symptoms of a clinically relevant illness in the 2 weeks before the first study day
* hypertension
* any known psychiatric condition
* abuse of alcoholic beverages, drug abuse
* known positive human immunodeficiency virus status
* any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
* participation in a clinical trial in the 4 weeks preceding the study
* known allergy against Midazolam
* known allergy against Fentanyl
* pregnancy or breast-feeding
* unable or unwilling to give informed consent
* unable or unwilling to follow investigator's instructions
* unable or unwilling to comply with study protocol

Answer: C