Status:
COMPLETED
Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Conditions:
ADHD
Substance Abuse
Eligibility:
All Genders
13-18 years
Phase:
PHASE3
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.
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00264797
Start Date
February 1 2006
End Date
October 1 2008
Last Update
June 7 2013
Active Locations (12)
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1
Synergy Treatment Center
Denver, Colorado, United States, 80219
2
Gateway Community Services
Jacksonville, Florida, United States, 32211
3
Operation PAR, Inc.
St. Petersburg, Florida, United States, 33709
4
Mountain Manor Treatment Programs
Baltimore, Maryland, United States, 21229