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Osmotic-Release Methylphenidate Randomized Controlled Trial for Adolescents with Attention-Deficit/Hyperactivity Disorders and Substance Use Disorders: A Missing Data Sensitivity Analysis.

Presented at the College on Problems of Drug Dependence (CPDD) annual meeting, San Juan, Puerto Rico, June 14-19, 2014.

Sterling McPherson, PhD, Mary Rose Mamey, Celestina Barbosa-Leiker, PhD, Sean Murphy, PhD, John M. Roll, PhD (all from Washington State University, PN Node).

The purpose of this study was to examine sensitivity to missing data procedures on treatment effects in a randomzied controlled trial (RCT) of osmotic-release methylphenidate (OROS) for adolescents with co-occurring attention-deficit/hyperactivity disorder (ADHD) and substance use disorders (SUD). Data came from a National Drug Abuse Treatment Clinical Trials Network study (CTN-0028, N=303), which evaluated the safety/efficacy of a 16-week RCT of OROS vs. placebo in adolescents aged 13-18 with ADHD who were also receiving cognitive-behavioral therapy for their SUD. The two primary outcomes were clinician-reported ADHD symptoms and self-reported past 28 days of substance use (SU). A parallel grow model was used to assess the effect sizes assuming missing at random (MAR) compared to two missing not at random (MNAR) models: Diggle-Kenward (DK) selection model and Wu-Carroll (WC) selection model.

The MAR model found no significant treatment effect on ADHD or SU, and the effect sizes were small for both ADHD and SU. The MNAR DK model also produced non-significant treatment effects with similar effect sizes of ADHD and SU. The MNAR WC model evidenced a significant effect of OROS relative to placebo on SU, and the effect sizes for both ADHD and SU were larger than reported in the other models.

Conclusions: While the MAR model and one MNAR model found similarly sized effects as the original RCT, the second MNAR model produced different results for both of the outcomes. This sensitivity analysis highlights an important need for future RCTs of co-morbid mental illness and SUDs to carefully evaluate the missing data assumptions made when assessing treatment effects. (Poster, PDF, English, 2014)

Keywords: Attention Deficit Hyperactivity Disorder (ADHD) | Adolescents | CTN platform/ancillary study | Data management | Osmotic-Release and Methylphenidate (OROS-MPH) | Missing data | Pharmacological therapy | College on Problems of Drug Dependence (CPDD) annual meeting, 2014

Document No: 1081.

Submitted by Sterling McPherson, PhD, PN Node, 7/21/2014.

Barbosa-Leiker, Celestina search mail
Mamey, Mary Rose search mail
McPherson, Sterling search mail
Murphy, Sean search mail
Roll, John M. search mail
NIDA-CTN-0028 search www

Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 7/2014 --