START Pharmacogenetics: Exploratory Genetic Studies in Starting Treatment with Agonist Replacement Therapies Wade Berretini, M.D., Ph.D. Co-Lead Investigator Professor, Department of Psychiatry Translational Research Laboratory Building 125 South 31st St. wadeb@mail.med.upenn.edu C. Lindsay DeVane, Pharm.D. Co-Lead Investigator Professor and Vice Chair for Research Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 67 President St. Charleston, SC 29425 devanel@musc.edu

This ancillary study is related to CTN-0027, "Starting Treatment with Agonist Replacement Therapies (START)."

This proposal outlines a supplementary pharmacogenetics component to the NIDA START trial (CTN-0027). Patients participating in START will be offered the opportunity to volunteer for a genetics study that has the primary objective of genotyping patients for exploratory analyses. Genomic DNA from blood samples sent to an NIH repository will be extracted and saved for study. Investigators at the University of Pennsylvania will study the frequency of gene variants that have primarily been associated with addiction, while the Medical University of South Carolina researchers will examine the relationship between treatment drug plasma concentrations and gene variants associated with drug disposition and transport. It is expected that the results of this study will contribute to the rational design of future clinical trials for hypothesis-driven pharmacogenetic studies that can be incorporated into the NIDA Clinical Trials Network (CTN).

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