American Journal on Addictions 2015;24(4):348-356. [doi: 10.1111/ajad.12193]
Sean X. Luo, MD, PhD, Lirio S. Covey, PhD, Mei-Chen Hu, PhD, Frances R. Levin, MD, Edward V. Nunes, MD (all from New York State Psychiatric Institute, GNY Node), Theresa M. Winhusen, PhD (University of Cincinnati, OV Node).
Osmotic-release oral system methylphenidate (OROS-MPH) did not show overall benefit as an adjunct smoking cessation treatment for adult smokers with ADHD in a randomized, placebo-controlled, multicenter study in the National Drug Abuse Treatment Clinical Trials Network (CTN-0029). A secondary analysis revealed a significant interaction between ADHD symptom severity and treatment-response to OROS-MPH, but did not account for other baseline covariates or estimate the magnitude of improvement in outcome if treatment were optimized. This present study addressed the gaps in how this relationship should inform clinical practice. Using data from the CTN trial (N=255, six sites in five US states), researchers built predictive models to calculate the probability of achieving prolonged abstinence, verified by self-report, and expired carbon monoxide measurement. The potential improvement in achieving prolonged abstinence was evaluated, both with and without stratification on baseline ADHD severity. Predictive modeling demonstrated that the interaction between baseline ADHD severity and treatment group was not affected by adjusting for other baseline covariates. A clinical trial simulation showed that giving OROS-MPH to patients with baseline Adult ADHD Symptom Rating Scale (ADHD-RS) >35 and placebo to those with ADHD-RS <= 35 would significantly improve the prolonged abstinence rate.
Conclusions: In smokers with ADHD, utilization of a simple decision rule that stratifies patients based on baseline ADHD severity can enhance overall achievement of prolonged smoking abstinence. This type of personalized treatment based on baseline ADHD symptom severity alone could significantly improve clinical outcome over randomized assignment. Similar analysis methods should be considered for future clinical trials for other substance use disorders. (Article (Peer-Reviewed), PDF, English, 2015)
Keywords: Attention Deficit Hyperactivity Disorder (ADHD) | Concerta | CTN platform/ancillary study | Osmotic-Release Methylphenidate (OROS-MPH) | Pharmacological therapy | Smoking | American Journal on Addiction (journal)
Document No: 1121, PMID: 25659348, PMCID: PMC4425992.
Submitted by CTN Dissemination Librarians, 2/11/2015.