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

University of Cincinnati303 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

303

Conditions

ADHD Substance Abuse

Interventions

Methylphenidate (OROS-MPH)DRUG

Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

Methylphenidate (OROS-MPH) - PlaceboDRUG

Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Synergy Treatment Center

Denver, Colorado, United States

Gateway Community Services

Jacksonville, Florida, United States

Operation PAR, Inc.

St. Petersburg, Florida, United States

Outcomes

Primary Outcomes

ADHD Severity

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.

Time frame: baseline and 20 weeks

Substance Use

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.

Time frame: 20 weeks

Secondary Outcomes

OROS-MPH Abuse Liability

Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.

Time frame: 20 weeks

Substance Use Outcomes

The mean number of negative urine drug screens (UDS).

Time frame: 20 weeks

Data from ClinicalTrials.gov

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