National Drug Abuse Treatment Clinical Trials Network A Randomized Controlled Trial of OROS-MPH + CBT in Adolescents with ADHD and Substance Use Disorders Robert Davies, M.D. Robert Davies, M.D. Associate Professor, Psychiatry Associate Professor, Psychiatry University of Colorado Denver School of Medicine University of Colorado Denver School of Medicine NATIONAL INSTITUTE ON DRUG ABUSE NID A
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National Drug Abuse Treatment Clinical Trials Network National Drug Abuse Treatment Clinical Trials Network A Randomized Controlled Trial of OROS-MPH +
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National Drug Abuse TreatmentClinical Trials Network
National Drug Abuse TreatmentClinical Trials Network
A Randomized Controlled Trial of OROS-MPH + CBT in Adolescents
with ADHD and Substance Use Disorders
Robert Davies, M.D.Robert Davies, M.D.Associate Professor, PsychiatryAssociate Professor, Psychiatry
University of Colorado Denver School of MedicineUniversity of Colorado Denver School of Medicine
A Randomized Controlled Trial of OROS-MPH + CBT in Adolescents
with ADHD and Substance Use Disorders
Robert Davies, M.D.Robert Davies, M.D.Associate Professor, PsychiatryAssociate Professor, Psychiatry
University of Colorado Denver School of MedicineUniversity of Colorado Denver School of Medicine
NATIONAL
INSTITUTE ON DRUG
ABUSE
NATIONAL
INSTITUTE ON DRUG
ABUSENIDNIDAA
Financial Disclosures
• Active medication and placebo Active medication and placebo provided by McNeil Pharmaceuticalsprovided by McNeil Pharmaceuticals
• Dr. Davies previously participated on Dr. Davies previously participated on Speaker’s Bureaus for Eli Lilly, PfizerSpeaker’s Bureaus for Eli Lilly, Pfizer
Background & Significance• ADHD 3-5x more common in adolescents ADHD 3-5x more common in adolescents
with SUD (30-50%) compared to those with SUD (30-50%) compared to those without SUD (7-10%) and is associated with without SUD (7-10%) and is associated with poorer treatment outcomespoorer treatment outcomes
• The safety and efficacy of psychostimulant The safety and efficacy of psychostimulant medication for ADHD in youths without medication for ADHD in youths without SUD is well-established, but SUD is well-established, but research is research is lacking in substance abusing adolescents lacking in substance abusing adolescents with ADHDwith ADHD
Study AimsStudy Aims
Aim 1Aim 1: To evaluate the efficacy of OROS-MPH : To evaluate the efficacy of OROS-MPH vs. placebo in treating ADHD is substance-vs. placebo in treating ADHD is substance-abusing adolescentsabusing adolescents
Aim 2Aim 2: To evaluate the impact of OROS-MPH : To evaluate the impact of OROS-MPH + CBT vs. placebo + CBT on substance + CBT vs. placebo + CBT on substance treatment outcomestreatment outcomes
Aim 3Aim 3: To evaluate the tolerability, safety, and : To evaluate the tolerability, safety, and abuse potential of OROS-MPH in substance-abuse potential of OROS-MPH in substance-abusing adolescents with ADHDabusing adolescents with ADHD
OROS-MPH PlaceboDSM IV ADHD symptom checklist score (adolescent) 38.1 (9.0) 39.3 (8.7)Number of Abuse and Dependence Diagnoses 2.1 (1.2) 1.9 (1.3)Number of Days Used Drugs (out of past 28) 14.0 (9.6) 15.1 (9.4)
147 Excluded (32.7%)139 Not eligible (94.6%) 8 Other (5.4%)
1334 Individuals Screened by Telephone
151 Included in Analysis
118 Completed Trial (78.1%) 33 Non-Completers (21.9%)11 Withdrew Consent 3 Moved from Area 2 Practical Problems 4 Incarceration 1 Pressure/Advice from Outsiders 9 Failed to Return to Clinic and Lost 3 Other
109 Completed Trial (71.7%) 43 Non-Completers (28.3%)11 Withdrew Consent 1 Moved from Area 3 Practical Problems 5 Incarceration 1 Pressure/Advice from Outsiders17 Failed to Return to Clinic and Lost 1 Feels Treatment not Working 4 Other
Do you remember to take medication 86.6 80.1 p = 0.143; NS
Do you think it helps 53.5 29.8 p < .0001
Ever sold you medication to others 2.1 1.4 p = 1.000; NS
Ever let others take your medication 3.5 1.4 p = 0.447; NS
Ever taken more than supposed to 4.2 2.8 p = 0.749; NS
Ever got high on medication 4.9 7.1 p = 0.444; NS
Ever taken med other than how prescribed 2.1 0.7 p = 0.622; NS
Ever not taken so that you could use drugs/alcohol
4.2 6.4 p = 0.418; NS
Ever used drugs/alcohol on days took med 67.6 72.3 p = 0.385; NS
Ever had a reaction to drugs/alcohol while taking medication
2.8 2.1 p = 1.000; NS
MGH Liking ScaleMGH Liking Scale
Item(Scoring Range 1 = not at all; 10 = very much)
OROS Placebo Significance*
Medication effective 6.0 4.5 p< .001
Like how it makes you feel 4.9 4.4 p = 0.058; NS
How high/euphoric do you get 2.7 2.1 p = 0.101; NS
How depressed/down do you get 2.4 2.0 p = 0.044
Do you ever crave medication 1.3 1.4 p = 0.673; NS
Crave other drugs when on med 2.4 2.5 p = 0.835; NS
How physically active do you feel 5.3 4.9 p = 0.034
*non-parametric tests
Summary of Summary of Main Study FindingsMain Study Findings
1. ADHD outcomes as good or better than in adolescents without SUD
2. OROS-MPH safe, well-tolerated
3. Results suggest contribution of CBT to both SUD and ADHD outcomes
4. Substance outcomes as good or better than in youth with less severe psychopathology
5. Treatment compliance, completion superior to that reported in studies of youths with less severe SUD and psychopathology
Interpretation of Results in Context Interpretation of Results in Context of Previous Researchof Previous Research
Results are inconsistentResults are inconsistent
• With most controlled trials of psychostimulant vs placebo (alone) for ADHD
Results are consistentResults are consistent
• With 3 controlled psychostimulant trials in adults concurrently receiving weekly individual CBT for SUD (Levin et al 2006; 2007; Schubiner et al 2004)
• With growing literature that cognitive behavioral and behavioral interventions effective for ADHD in adults and youth without SUD (Safren et al, 2005; Fabiano et al, 2009; Solanto et al, 2010)
If replicated, results have important If replicated, results have important clinical implicationsclinical implications
• Results suggest that clinically significant reductions in co-occurring ADHD symptoms may be important in helping adolescents achieve greater abstinence during substance treatment.
• In the context of individual CBT (for SUD), significant reductions in ADHD symptoms may occur with or without pharmacotherapy.
• If ADHD does not improve early in treatment, OROS-MPH may be considered as safe and likely effective pharmacotherapy for ADHD even if not yet abstinent (with regular monitoring and in the context of ongoing substance treatment)
• OROS-MPH demonstrated low abuse/diversion liability.• Secondary outcomes indicated some added benefit with