The purpose of this study is to determine the efficacy of OROS-MPH vs. placebo for the treatment of ADHD in adolescents with SUD.

Condition	Intervention	Phase
ADHD Substance Abuse	Drug: Methylphenidate (OROS-MPH)	Phase III

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcomes: ADHD severity; Substance use
Secondary Outcomes: OROS-MPH abuse liability; Substance Use Treatment Outcomes
Expected Total Enrollment:  300

Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance 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 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.

Ages Eligible for Study:  13 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Meet 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 three months prior to signing consent

Please refer to this study by ClinicalTrials.gov identifier  NCT00264797

Marilyn Macdonald      303-315-8133    Marilyn.Macdonald@UCHSC.edu
Catherine Dempsey, Ph.D.      303-315-1319    Catherine.Dempsey@UCHSC.edu

Colorado
      Synergy Treatment Center, Denver,  Colorado,  80219,  United States
Massachusetts
      SSTAR: Stanley Street Treatment & Resources, Inc, Fall River,  Massachusetts,  02720-6009,  United States
South Carolina
      LRADAC, Columbia,  South Carolina,  29205,  United States

Study chairs or principal investigators

Paula Riggs, M.D.,  Principal Investigator,  University of Colorado   
Theresa Winhusen, Ph.D.,  Principal Investigator,  University of Cincinnati   

Study ID Numbers:  NIDA-CTN-0028
Last Updated:  December 12, 2005
Record first received:  December 10, 2005
ClinicalTrials.gov Identifier:  NCT00264797
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10