Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

University of Cincinnati

Status and phase: Completed; Phase 3

Conditions: Substance Abuse; ADHD

Treatments: Drug: Methylphenidate (OROS-MPH) - Placebo; Drug: Methylphenidate (OROS-MPH)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00264797

5U10DA013732 (U.S. NIH Grant/Contract)

NIDA-CTN-0028

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 303 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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303 participants in 2 patient groups, including a placebo group

Methylphenidate

Active Comparator group

Treatment:

Drug: Methylphenidate (OROS-MPH)

Methylphenidate (Placebo)

Placebo Comparator group

Treatment:

Drug: Methylphenidate (OROS-MPH) - Placebo