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Phase 3 N=303 Randomized Quadruple-blind Treatment

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

ADHD · Substance Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00264797 ↗
Enrolled (actual)
303
Serious AEs
3.6%
Results posted
Jun 2013
Primary outcome: Primary: ADHD Severity — -20.6; -21.8 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Methylphenidate (OROS-MPH) (Drug); Methylphenidate (OROS-MPH) - Placebo (Drug)
Age
Pediatric, Adult · 13+ yrs
Sex
All
Sponsor
University of Cincinnati
Primary completion
Oct 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
ADHD Severity		 -20.6; -21.8 —
PRIMARY
Substance Use		 -5.7; -5.2 —
SECONDARY
OROS-MPH Abuse Liability		 15.4; 9.7 —
SECONDARY
Substance Use Outcomes		 3.8; 2.8 —

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00264797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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