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

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ClinicalTrials.gov Identifier: NCT00264797
Recruitment Status : Completed
First Posted : December 13, 2005
Results First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Information provided by (Responsible Party):
Theresa Winhusen, University of Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Substance Abuse Drug: Methylphenidate (OROS-MPH) Drug: Methylphenidate (OROS-MPH) - Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Study Start Date : February 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. ADHD Severity [ Time Frame: 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.

  2. Substance Use [ Time Frame: 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.


Secondary Outcome Measures :
  1. OROS-MPH Abuse Liability [ Time Frame: 20 weeks ]
    Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.

  2. Substance Use Outcomes [ Time Frame: 20 weeks ]
    The mean number of negative urine drug screens (UDS).


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264797


Locations
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United States, Colorado
Synergy Treatment Center
Denver, Colorado, United States, 80219
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32211
Operation PAR, Inc.
St. Petersburg, Florida, United States, 33709
United States, Maryland
Mountain Manor Treatment Programs
Baltimore, Maryland, United States, 21229
United States, Massachusetts
SSTAR: Stanley Street Treatment & Resources, Inc
Fall River, Massachusetts, United States, 02720-6009
United States, Missouri
Crittenton
Kansas City, Missouri, United States, 64134
United States, New York
St. Luke's-Roosevelt Hospital, Child and Family Institute
New York City, New York, United States, 10025
United States, Pennsylvania
Rehab After Work-Life Counseling Services
Paoli, Pennsylvania, United States, 19301
Addiction Medicine Services
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
SSTAR of Rhode Island
North Kingstown, Rhode Island, United States, 02852
United States, South Carolina
LRADAC
Columbia, South Carolina, United States, 29205
United States, Texas
Mental Health and Retardation of Tarrant County
Fort Worth, Texas, United States, 76107
Sponsors and Collaborators
University of Cincinnati
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Investigators
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Principal Investigator: Paula Riggs, M.D. University of Colorado, Denver
Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Theresa Winhusen, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00264797    
Other Study ID Numbers: NIDA-CTN-0028
5U10DA013732 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2005    Key Record Dates
Results First Posted: June 7, 2013
Last Update Posted: June 7, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Chemically-Induced Disorders
Methylphenidate
Central Nervous System Stimulants
 Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents