Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD) (NIDA-CTN-0028) - PowerPoint PPT Presentation

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Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD) (NIDA-CTN-0028)

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... once daily dosing Equivalent efficacy to short acting psychostimulants Controlled delivery system likely reduces abuse potential Standardized SUD Treatment ... – PowerPoint PPT presentation

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Title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD) (NIDA-CTN-0028)


1
Study Design for a Randomized Controlled Trial
of Osmotic-Release Methylphenidate
(OROS-MPH) for Attention Deficit
Hyperactivity Disorder in Adolescents
with Substance Use Disorders
Presenter Theresa Winhusen, Ph.D.
June 14, 2006, Pharmacological Treatment of ADHD
in Substance-Abusing Adolescents and Adults New
Findings, Research Directions, and Clinical
Implications 310 330
2
Principal Investigators
  • Principal Investigator
  • Paula Riggs MD University of Colorado at Denver
    Health Sciences Center (UCDHSC)
  • Co-Principal Investigators
  • Theresa Winhusen PhD
  • Robert Davies MD, Medical Co LI (UCDHSC)

3
Background Significance
  • 30-50 of adolescents in substance treatment have
    ADHD
  • ADHD associated with
  • More severe substance abuse
  • Worse behavior problems
  • Poorer treatment outcomes

4
Background Significance
  • Integrated treatment is considered to be a core
    drug treatment principle (NIDA, 1999)
  • Recent community treatment survey
  • lt 50 had dual diagnosis programs
  • Of those with dual diagnosis programs
  • 43.4 did not offer prescription meds
  • 37.8 did not offer psychiatric/psychological
    evaluation
  • Motjabai, 2004

5
Background Significance
  • One RCT targeting ADHD in adolescents with
    co-occurring SUD
  • 12 week trial pemoline n69, adolescents 13-19
  • Similar safety, efficacy for ADHD as in
    adolescents without SUD
  • No impact on drug use in the ABSENCE of specific
    substance treatment

Riggs et al 2004
Schedule 1V psychostimulant
6
Treatment of ADHD /- SUD
  • Schedule II psychostimulants, gold standard
  • Non-scheduled alternatives-- bupropion and
    atomoxetine-- have lower effect sizes (.5 and .7)
  • OROS-MPH/Concerta
  • Long acting (12 hours) once daily dosing
  • Equivalent efficacy to short acting
    psychostimulants
  • Controlled delivery system likely reduces abuse
    potential

7
Standardized SUD Treatment
  • Individual Manualized Cognitive Behavioral
  • Therapy (CBT)
  • Found effective for SUD in adolescents
  • Individual, not group, due to feasibility
  • 16 sessions, including up to 3 family
  • sessions

8
Study Objectives
  • Primary Objectives
  • 1a Evaluate safety and efficacy of OROS-MPH vs.
    Placebo for ADHD in adolescents with SUD
  • 1b Evaluate impact of treatment of ADHD with
    OROS-MPH on substance treatment outcomes

9
Study Design
  • 16-week randomized controlled trial
  • OROS-MPH (72mg/day) vs placebo
  • CBT for SUD
  • Weekly
  • Outpatient
  • Power
  • N 300 to detect low/medium effect size (.4)
  • 11 study sites

10
Study Sites
  • Wave 1
  • LRADAC, South Carolina
  • Synergy, Colorado
  • STARR, Northern New England
  • Wave 2
  • Operation PAR, Florida
  • Gateway, Florida
  • Mountain Manor, Mid-Atlantic
  • Crittenton, Ohio Valley
  • St Lukes Roosevelt, Long Island
  • MHMR of Tarrant County, Texas
  • Rehab After Work, Delaware Valley
  • Addiction Medicine Services, Appalachian Tri
    State

11
Study Participants
  • Participants
  • Inclusion
  • Adolescents (13-18)
  • DSM IV ADHD
  • At least one SUD
  • Exclusion
  • serious medical illness
  • bipolar
  • psychosis
  • opiate dependence
  • methamphetamine abuse, dependence
  • other treatment psychotropics

12
Primary Outcome Measures
  • DSM-IV ADHD Symptom Checklist
  • Number of Use Days
  • -Substance Use Self-Report using the TLFB

13
Other Efficacy Measures
  • ADHD
  • Clinician Global Impression of
  • Improvement (CGI-I) Rating Scale
  • Substance Use Outcomes
  • Frequency of Drug Use (TLFB)
  • Urine Toxicology
  • Proportion of Negative Urines

14
Safety Measures
  • Vital Signs/Weight
  • Pregnancy Test
  • Adverse Events
  • Prior/Concomitant Medications
  • Lab values (urinalysis, CBC, LFTs)

15
Study Progress
  • Wave 1 Sites Initiated March 2006
  • Wave 2 Site Initiation June-July 2006

16
Study Progress - Wave 1
17
Referral Sources - Wave 1
18
Pre-Screen Ineligibility-Wave 1
19
Medication Tolerability - Wave 1
20
Study Timeline Enrollment Schedule
  • 2006
  • A/4 M/5 J/6 J/7 A/8 S/9 O/10 N/11
    D/12
  • 6 12 18 21 43 65 87
    109 131
  • 2007
  • J/1 F/2 M/3 A/4 M/5 J/6 J/7
    A/8
  • 153 175 197 219 241 263 285 307
  • S/9 O/10 N/11 D/12
  • 2008
  • J/1 F/2 M/3 A/4

Initial projection enrollment completion
midpoint
enrollment completed
16 wk study completion
F/u study completion
Study close out, data lock, manuscript preparation
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