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

Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

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.

Study Overview

• Status: Completed
• Conditions: ADHD; Substance Abuse
• Intervention / Treatment: Drug: Methylphenidate (OROS-MPH); Drug: Methylphenidate (OROS-MPH) - Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80219
      • Synergy Treatment Center
  • Florida
    • Jacksonville, Florida, United States, 32211
      • Gateway Community Services
    • St. Petersburg, Florida, United States, 33709
      • Operation PAR, Inc.
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Mountain Manor Treatment Programs
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720-6009
      • SSTAR: Stanley Street Treatment & Resources, Inc
  • Missouri
    • Kansas City, Missouri, United States, 64134
      • Crittenton
  • New York
    • New York City, New York, United States, 10025
      • St. Luke's-Roosevelt Hospital, Child and Family Institute
  • Pennsylvania
    • Paoli, Pennsylvania, United States, 19301
      • Rehab After Work-Life Counseling Services
    • Pittsburgh, Pennsylvania, United States, 15213
      • Addiction Medicine Services
  • Rhode Island
    • North Kingstown, Rhode Island, United States, 02852
      • SSTAR of Rhode Island
  • South Carolina
    • Columbia, South Carolina, United States, 29205
      • LRADAC
  • Texas
    • Fort Worth, Texas, United States, 76107
      • Mental Health and Retardation of Tarrant County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methylphenidate	Drug: Methylphenidate (OROS-MPH); 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.
Placebo Comparator: Methylphenidate (Placebo)	Drug: Methylphenidate (OROS-MPH) - Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OROS-MPH Abuse Liability	Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.	20 weeks
Substance Use Outcomes	The mean number of negative urine drug screens (UDS).	20 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institute on Drug Abuse (NIDA); University of Colorado, Denver
• Investigators: Principal Investigator: Theresa Winhusen, Ph.D., University of Cincinnati; Principal Investigator: Paula Riggs, M.D., University of Colorado, Denver

Publications and helpful links

General Publications

• Riggs PD, Winhusen T, Davies RD, Leimberger JD, Mikulich-Gilbertson S, Klein C, Macdonald M, Lohman M, Bailey GL, Haynes L, Jaffee WB, Haminton N, Hodgkins C, Whitmore E, Trello-Rishel K, Tamm L, Acosta MC, Royer-Malvestuto C, Subramaniam G, Fishman M, Holmes BW, Kaye ME, Vargo MA, Woody GE, Nunes EV, Liu D. Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. J Am Acad Child Adolesc Psychiatry. 2011 Sep;50(9):903-14. doi: 10.1016/j.jaac.2011.06.010. Epub 2011 Aug 4.
• Tamm L, Trello-Rishel K, Riggs P, Nakonezny PA, Acosta M, Bailey G, Winhusen T. Predictors of treatment response in adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder. J Subst Abuse Treat. 2013 Feb;44(2):224-30. doi: 10.1016/j.jsat.2012.07.001. Epub 2012 Aug 11.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 10, 2005
• First Submitted That Met QC Criteria: December 10, 2005
• First Posted (Estimate): December 13, 2005

Study Record Updates

• Last Update Posted (Estimate): June 7, 2013
• Last Update Submitted That Met QC Criteria: May 2, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: NIDA-CTN-0028; 5U10DA013732 (U.S. NIH Grant/Contract)