Participating Organizations

Tracy Nolen, DrPH - Project Director and Principal Investigator

Dr. Tracy Nolen is a senior research statistician with more than 16 years of experience providing and managing analytic support for observational studies and clinical trials funded by commercial pharmaceutical and device companies, the Department of Defense (DoD), Department of Veteran Affairs (VA), and the National Institutes of Health (NIH). Dr. Nolen holds a Doctorate of Public Health degree in Biostatistics from the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health and a master’s degree in Statistics from North Carolina State University. She specializes in the design, set-up, operation, analysis as well as scientific and regulatory reporting of clinical trials. Her statistical experience includes causal inference in observational and randomized trials settings; alternative study designs including adaptive dose finding designs and adaptive randomization algorithms; and the use of various statistical methods (e.g., regression analysis, including generalized linear models; longitudinal data analysis, including generalized estimating equation (GEE) and mixed models; survival analysis; nonparametric analysis; dose-proportionality analysis). She is a PASA Data Coordinating Center Project Director and Principal Investigator.

Rick Williams, PhD - Co-Principal Investigator

Dr. Rick Williams is a fellow of the American Statistical Association (ASA) with more than 35 years of experience in medical and epidemiological research. He has led eight major multisite research projects coordinating the efforts of dozens of research sites across the US. He designs and leads population surveys, observational studies, and randomized clinical trials. He frequently conducts workshops and training classes on the use of statistical analysis methods for cluster-correlated, longitudinal, or repeated measures data, such as generalized estimating equations for marginal models, hierarchical linear and nonlinear mixed models, and multilevel models. He has also led the selection and implementation of data capture and data management systems for clinical studies at RTI International. He holds a Ph.D. in Biostatistics with specialization in Epidemiology. Dr. Williams is the PASA Data Coordinating Center Co-Principal Investigator.

Meg Crawford – Clinical Research Manager

Meg Crawford is a research clinical studies specialist and manager in the Center for Clinical Research Network Coordination at RTI International. She has more than 15 years of experience managing clinical trials in multi-site networks, is certified as a clinical research professional, and is trained in good clinical practices. Ms. Crawford serves as the clinical research manager on the Pharmacotherapies for Alcohol and Substance Abuse Consortium (PASA). Her responsibilities include developing protocols, study manuals, and informed consent documents; developing or monitoring case report forms; reviewing adverse event experience reports; and ensuring protection of subjects and subjects’ rights through institutional review board relations. Ms. Crawford’s responsibilities also include budget development, report preparation, education and protocol training of other research professionals, project administration, and research project audits.

Thomas Kosten, M.D.

Dr. Kosten is a professor and the Jay H. Waggoner Endowed Chair in the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine (BCM), as well as the co-director of the Dan L. Duncan Institute for Clinical and Translational Research (ICTR) at BCM. He has led National Institutes of Health (NIH) and VA Research Centers and randomized clinical trials for over 30 years and has been PI on several national multisite studies for developing new medications in many addictions and post-traumatic stress disorder (PTSD). He has directed a National Institute on Drug Abuse (NIDA) Medications Development Center since 1988 and has been the Research Director of the VA National Substance Use Disorders Quality Enhancement Research Initiative (QUERI) based at the Michael E. DeBakey VA Medical Center (MEDVAMC). He is the founding Vice Chair for Addiction Psychiatry of the American Board of Psychiatry and Neurology, and Past President of both the American Academy of Addiction Psychiatry (AAAP) and the College on Problems of Drug Dependence (CPDD). He is a Distinguished Life Fellow in the American Psychiatric Association (APA) and a Fellow of the American College of Neuropsychopharmacology (ACNP). He has served as a Congressional Fellow in the US House of Representatives and has been a long-standing member of various substance abuse commissions for the National Academy of Sciences (NAS), as well as various advisory boards for the Food and Drug Administration (FDA) and the Department of Defense (DoD). He is the current editor for the American Journal on Addictions, past Editor for the American Journal of Drug and Alcohol Abuse and serves on the board of several notable journals in substance abuse. He has published over 700 papers, books, and reviews describing his contributions, particularly in the use of pharmacotherapeutics for treating cocaine and opioid addictive disorders, as well as his work in vaccine development for cocaine and methamphetamine addictions. Dr. Kosten is the Co-PI for the PASA Consortium. He is also the Co-PI for the PASA funded study entitled “PT150 as a Potential Treatment for Alcohol Use Disorder- Alcohol Interaction Study”, as well as the Co-PI for the “Zonisamide as a New Treatment for Post-Traumatic Stress Disorder and Co-Occurring Alcohol Use Disorder Study”.

www.bcm.edu

Christopher Verrico, Ph.D.

Dr. Christopher Verrico is an assistant professor in the Department of Pharmacology at Baylor College of Medicine (BCM) with nearly 20 years of training and experience conducting research in the area of substance use disorders (SUD). His past research has focused on discovering and evaluating treatments for narcotic and alcohol addictions. He has experience in both animal and clinical research on different forms of addiction. He has led clinical research projects with Veterans at the Michael E. DeBakey VA Medical Center (MEDVAMC) and the National Institutes of Health (NIH), including the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). He currently directs two NIH-funded clinical studies that are being conducted at the MEDVAMC. For the past year, he has lead Dr. Newton’s NIDA-funded study (R01 DA 035513) evaluating the efficacy of treatment with both modafinil and doxazosin for reducing cocaine-induced effects. He also directs Dr. Newton’s NIAAA-funded study (R42 AA 22049) exploring the efficacy of carisbamate for treating alcohol use disorder (AUD) in civilians. Dr. Verrico is the PI of the following PASA-funded clinical trials, “ Lofexidine Combined with Buprenorphine for Reducing Symptoms of Post-Traumatic Stress Disorder and Opioid Use Relapse in Veterans” and “Effects of Ethanol on the Pharmacokinetics of PT-150.”

www.bcm.edu

Howard C. Becker, Ph.D.

Dr. Howard C. Becker is a professor in the Departments of Psychiatry and Neuroscience at the Medical University of South Carolina (MUSC) and a Senior Research Career Scientist at the Ralph H. Johnson VA Medical Center. Dr. Becker has over 30 years of research experience in the use of animal models to determine the basic mechanisms of alcohol and drug action in the brain. Additionally, as Director of the Charleston Alcohol Research Center, Dr. Becker coordinates preclinical and clinical investigations that focus on identifying and evaluating alcohol treatment targets and strategies. He also serves as the Scientific Director for the NIAAA-supported Integrative Neurobiology Initiative on Alcoholism (INIA-Stress) Consortium, a multi-institutional consortium focused on understanding the neuroadaptive changes that result from the complex interaction between stress, anxiety, and alcohol use/misuse in several species (rodents, monkeys, and humans). He is the PI of the PASA-funded preclinical study entitled “Preclinical Analysis of Combined Zonisamide and Doxazosin Treatments in Stress-Alcohol Drinking Models”.

http://academicdepartments.musc.edu/musc/

Marcelo Lopez, Ph.D.

Dr. Marcelo Lopez is an associate professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina (MUSC), a Principle Investigator of the INIA-Stress Consortium Mouse CIE Core, and the Animal Core Supervisor of the Shared Resources Core within the Charleston Alcohol Research Center. Dr. Lopez has extensive experience in conducting behavioral pharmacology studies that utilize numerous rodent models of alcohol exposure, including a chronic intermittent ethanol (CIE) exposure model that produces escalation of drinking. Dr. Lopez was instrumental in the development of the CIE model, which is now widely employed in the alcohol research field. He has also studied the complex interaction of stress and alcohol, work which led to the development of several stress/PTSD models. He is the Co-Investigator of the PASA-funded preclinical study entitled “Preclinical Analysis of Combined Zonisamide and Doxazosin Treatments in Stress-Alcohol Drinking Models”.

http://academicdepartments.musc.edu/musc/

Colin N. Haile, M.D., Ph.D.

Dr. Colin N. Haile is a research assistant professor in the Department of Psychology and Operations Director of the Animal Behavioral Core (ABC), a core facility designed to conduct experimental procedures in rats and mice, at the University of Houston. Dr. Haile has nearly 20 years of experience in evaluating potential pharmacotherapies for psychiatric diseases in humans and in animal models. He has a broad range of experience in molecular, behavioral, and clinical experimental procedures, and has published extensively on using a variety of behavioral assays for medication development. Dr. Haile also has a joint appointment at the Michael E. DeBakey VA Medical Center (MEDVAMC), where he is involved in clinical trials assessing medications for anxiety and substance use disorders (SUD) in Veterans. He is the PI of the PASA-funded preclinical study entitled “Assessing Pharmacotherapies in Animal Models of PTSD and AUD”.

http://www.uh.edu/

Therese Kosten, Ph.D.

Therese A Kosten PhD is Professor of Psychology at the University of Houston. The overarching theme of her research program is to understand the contributions of genetic and environmental factors that influence and shape behavior via the involvement of the hypothalamic-pituitary-adrenal (HPA) axis and dopaminergic and noradrenergic systems. She studies how behaviors reflective of addiction (e.g., self-administration, conditioned place preference, etc) are affected by stress, sex, and early life manipulations. Another aspect of her research can be considered translational as it involves medication development. For example, her laboratory is constructing and testing vaccines for methamphetamine abuse, and they are identifying new pharmacological targets for alcoholism that they test using maintenance and reinstatement of operant responding for alcohol procedures. Broadly, her research program encompasses the areas of motivation, emotion, and learning with a focus on limbic regions, such as the nucleus accumbens and hippocampus. Dr. Kosten is the Co-PI for the PASA study entitled “Assessing Pharmacotherapies in Animal Models of Post- Traumatic Stress Disorder and Alcohol Use Disorder”.

http://www.uh.edu/

Lori Davis, M.D.

Lori Davis, MD, is Associate Chief of Staff for Research at the Tuscaloosa VA Medical Center and Professor of Psychiatry in the Department of Psychiatry, University of Alabama Health System, in Birmingham and Tuscaloosa, AL. She received her undergraduate degree from Duke University and her medical degree from the University of North Carolina at Chapel Hill. She completed psychiatry residency at the University of Alabama at Birmingham. Dr. Davis has been conducting clinical trials in the treatment of posttraumatic stress disorder, major depression, and addictions for over 25 years. She was a member of the American Psychiatric Association Mood Disorders Workgroup on DSM-5 and is a member of the 2017 VA-DoD workgroup for the revision of the Clinical Practice Guidelines for PTSD. She is Study Chair for the VA Cooperative Study Program multisite trial evaluating the efficacy of Individual Placement and Support supported employment in the rehabilitation of unemployed Veterans with PTSD. Dr. Davis is the PI for the PASA funded clinical trial, “Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder and Comorbid PTSD.” This study focuses on kappa-opioid receptor antagonism in the treatment of veterans and service members recovering from alcohol use disorders (AUD) and comorbid posttraumatic stress disorder (PTSD). The multi-site study evaluates the efficacy and physiological effects of sublingual buprenorphine (Subutex) combined with extended-release injectable naltrexone (Vivitrol) in the treatment of comorbid AUD and PTSD. Sublingual buprenorphine, which acts as an antagonist at kappa and partial agonist of the mu receptors, combined with extended-release injectable naltrexone, which blocks the mu receptor, yields a pharmacologically net effect of kappa opioid receptor (KOR) antagonism.

https://www.tuscaloosa.va.gov/TUSCALOOSA/services/research/TREAC.asp

Ismene Petrakis, M.D.

Dr. Ismene Petrakis is Professor of Psychiatry at the Yale University School of Medicine and the Chief of Psychiatry and Mental Health Services at VA Connecticut Healthcare System. She is also the Director of the Addiction Psychiatry Residency at Yale University School of Medicine and the principal investigator of a National Institute of Drug Abuse (NIDA-T32) training grant. She is involved in the education of medical students and residents at many stages of their training, particularly around clinical issues of addictive disorders. She is also a grant funded investigator (funding sources over the years have included NIH, VA, Department of Defense, NARSAD and the Stanley Foundation) whose research interests include developing an understanding of the neurobiology of alcohol dependence and in testing potentially effective treatments for individuals with alcohol dependence and comorbid Axis I psychiatric disorders, particularly PTSD. Dr. Petrakis is the Co-PI for the PASA trial, “Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder and Comorbid PTSD.” Dr. Petrakis received her undergraduate degree at Northwestern University and her medical training at the University of Pittsburgh, School of Medicine. She completed her residency training at Yale University School of Medicine and then completed an Addiction Psychiatry Fellowship, also at Yale University. Since completing her training, Dr. Petrakis has over 20 years of experience in the clinical treatment of addictive disorders, research in this field and in the education of residents, medical students, post-doctoral fellows and other mental health trainees in the assessment, accurate diagnosis and treatment of patients with addictive disorders, particularly in those with comorbidity.

Dewleen Baker, M.D.

Dr. Dewleen Baker is a professor in the Department of Psychiatry at the University of California, San Diego (UCSD), Director of Neuroscience/Research at the San Diego Center of Excellence (CESAMH), Director of the Research and Neuroscience Unit, and a teaching attending in the Anxiety Disorders Unit of the San Diego VA Health System (VASDHS). Her research focuses on various aspects of stress and mental health, particularly post-traumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI). Within this focus, her clinical and research activities include projects in neuroscience and neurobiology), treatment of PTSD and mTBI and co-occurring mental and physical disorders (e.g. metabolic and immune-related disorders). She is the PI of the PASA-funded clinical trial entitled “Efficacy and Safety Study of PT150 (formally ORG 34517) in Veterans with Co-morbid PTSD/AUD” and co-PI of the PASA-funded clinical trial entitled “PT150 (formerly ORG 34517) as a Potential Treatment for Alcohol Dependence – Alcohol Interaction Study”.

http://ucsd.edu/

Victoria Risbrough, Ph.D.

Dr. Victoria Risbrough is an associate professor in the Department of Psychiatry at the University of California, San Diego (UCSD), Associate Director of Neuroscience/Research at the San Diego Center of Excellence (CESAMH), a member of the Molecular Neuropharmacology and Signaling study section for National Institutes of Health (NIH), and Director of the Neurocognition Project for the Marine Resiliency Study funded by the US Navy Bureau of Medicine and Surgery (BUMED). Dr. Risbrough’s research is centered on translational mechanisms and treatments of anxiety disorders using preclinical and clinical approaches. Her primary focus is to identify mechanisms of risk and resilience to anxiety disorders, particularly post-traumatic stress disorder (PTSD), as well as development of new pharmacological treatments for these disorders. Her program also identifies genetic and environmental contributions to stress behavior and fear learning. By measuring physiological responses to stress (including heart rate and startle reactivity) in animal models and in clinic, her research develops translational probes of anxiety responding and treatment efficacy. She is the co-PI of the PASA-funded clinical trial entitled “Efficacy and Safety Study of PT150 (formally ORG 34517) in Veterans with Co-morbid PTSD/AUD”.

http://ucsd.edu/

Luba Yammine, PhD, APRN, FNP-C

Dr. Yammine is an Associate Professor in the Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences at the University of Texas Health Science Center at Houston (UTHealth) McGovern Medical School. She has a without-compensation appointment at the Michael E. DeBakey VA Medical Center (MEDVAMC) and is fully certified by the VA Research and Development (R&D) Committee to conduct research involving Veterans at the VA. Dr. Yammine has received multiple awards for academic achievements, clinical practice, and research. Currently, she is conducting a UTHealth Center for Clinical and Translational Sciences (CCTS) Award-funded clinical trial evaluating exenatide as a potential treatment for smoking cessation (Yammine et al., 2018). This double-blinded randomized controlled trial is being conducted at the UTHealth Center for Neurobehavioral Research on Addictions (CNRA) in collaboration with Dr. Joy Schmitz, PhD. Prior to the receipt of the CCTS Scholar award, Dr. Yammine was a postdoctoral fellow in addictions research at Baylor College of Medicine (BCM), where she, along with Dr. Verrico, was involved in a series of human laboratory studies. The results of this work have been presented and published (De La Garza et al., 2019), with additional publications under development. In addition to research experience, Dr. Yammine brings in clinical expertise to the PASA consortium. She has over 10 years of experience as a Family Nurse Practitioner working directly with patients with a variety of mental health disorders, including posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD), among others.

Seth Norrholm, PhD

Dr. Seth Norrholm earned his B.A. degree in psychology at the University of Maryland at College Park, a M.A. degree in psychology/neuroscience at the University of Connecticut Health Center and a Ph.D. in psychology/neuroscience at Florida State University. Dr. Norrholm is a translational neuroscientist who studies trauma-, stressor- and anxiety-related disorders in combat and civilian populations. The primary objective of his work is to develop bench-to-bedside clinical research methods to inform therapeutic interventions for posttraumatic stress disorder and the disorders with which it is co-morbid. He has developed a conditioned fear extinction paradigm using fear-potentiated startle - a methodology that has the potential to be an effective outcome measure for PTSD treatment as well as an index of fear recovery.

John Krystal, MD

Dr. Krystal is a leading expert in the areas of alcoholism, post-traumatic stress disorder, schizophrenia, and depression. His work links psychopharmacology, neuroimaging, molecular genetics, and computational neuroscience to study the neurobiology and treatment of these disorders. He is best known for leading the discovery of the rapid antidepressant effects of ketamine in depressed patients. He is a member of the U.S. National Academy of Medicine. He also serves in a variety of advisory and review capacities for NIAAA, NIMH, Wellcome Trust, Brain and Behavior Research Foundation, the Broad Institute, and the Karolinska Institutet. Dr. Krystal previously served on the National Alcohol Abuse and Alcoholism Advisory Council (NIAAA), the Department of Defense Psychological Health Advisory Committee, and the NIMH Board of Scientific Counselors (chair, 2005-2007). He has led the American College of Neuropsychopharmacology (president, 2012), and International College of Neuropsychophamacology (president, 2016-2018). Currently, he is co-chair of the Neuroscience Forum (NeuroForum) of the National Academies of Sciences, Engineering, and Medicine, a member of the NIMH National Mental Health Advisory Council, and he edits the journal, Biological Psychiatry (impact factor: 11.982).

Michael Bardo, PhD

Dr. Bardo received his Ph.D. in Experimental Psychology in 1980 at Iowa State University under the supervision of Dr. Richard Hughes. His dissertation investigated the development of tolerance to morphine in infant rats. From 1980-82, Dr. Bardo worked as a postdoctoral scholar in the Department of Pharmacology at the University of Iowa under the supervision of Dr. Gerald Gebhart. Since 1982, he has been in the Department of Psychology at the University of Kentucky. Dr. Bardo has worked in the field of neuropsychopharmacology and drug abuse for over 35 years, having been funded continuously by NIH since 1981 and publishing over 200 research articles. His research interests are investigating the neurobehavioral effects of environmental enrichment and social influences on drug self-administration. Dr. Bardo is also interested in medication development for substance use disorders. In addition to behavioral processes, Dr. Bardo’s laboratory conducts work using chemogenetics, immunohistochemsitry, stereotaxic surgery and microdialyis with HPLC.

Marisa Roberto, PhD

Dr. Roberto has been PI on several independent NIH-funded research grants. She is the Scientific Director of the NIH-funded The Scripps Research Institute Alcohol Research Center. Dr. Roberto’s research focus is to understand which specific neuronal mechanisms undergo synaptic or molecular changes to influence the development of drug and alcohol dependence. She has a broad background using electrophysiological, pharmacological and molecular methods to study many aspects of synaptic plasticity that play a role in the behavioral effects of acute and chronic drug consumption. In 2005, she was awarded the Young Investigator Award from RSA. In 2008, she received the Presidential Early Career Awards for Scientists and Engineers, which is the highest honor bestowed by the U.S. government on outstanding scientists and engineers beginning their independent careers. Recently, she was awarded The Jacob P. Waletzky Award from the Society for Neuroscience (2016). She has demonstrated critical adaptations in the functional influence of endocannabinoids, neuroimmune pathways and several neuropeptides (e.g., CRF, NPY, N/OFQ, etc.) on GABAergic and glutamatergic transmission in the amygdala, providing evidence that these adaptations contribute to the development of negative reinforcement mechanisms that sustain alcohol and drug dependence.

Eric P. Zorrilla, PhD

Dr. Eric Zorrilla, Associate Professor, TSRI, will be Co-PI and oversee all aspects of experimental design for the proposed behavioral experiments. He will run experiments and supervise personnel, coordinate activities related to data collection and analysis, and prepare manuscripts for publication. Dr. Zorrilla has decades of experience studying behavioral aspects of stress and motivation, beginning as an undergraduate. Both Drs. Roberto and Zorrilla are experts in the field of alcohol use disorders (AUDs), the contribution of stress to AUDs, and the neurobiology of circuitry underlying these disorders. Drs. Roberto and Zorrilla have recruited an excellent consultant and expert in the field of anxiety and TSD disorders, Dr. Kerry Ressler. Dr. Ressler, at McLean Hospital, Depart. of Psychiatry, Harvard Medical School. is a physician-scientist expert in stress and fear-related disorders and the various risk factors for these psychopathologies. He also has particular expertise in the biology and drug discovery associated with FKBP5 systems and will assist with experimental design and translational interpretation of the data.

Astellas Pharma

Assessing Pharmacotherapies in Animal Models of Post-Traumatic Stress Disorder and Alcohol Use Disorder (AS140026-A2) – Dr. Colin N. Halie

POP TEST™

Efficacy and Safety Study of PT150 (formerly ORG 34517) in Veterans with Co-morbid PTSD/AUD (AS140026-A3a), PT150 (Formerly ORG34517) as a Potential Treatment for Alcohol Use Disorder – Alcohol Interaction Study (AS140026-A3b), and Effects of Ethanol on the Pharmacokinetics of PT-150 (AS140026-A3c). – Dr. Christopher Verrico and Dr. Dewleen Baker

Alkermes

Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder and Comorbid PTSD – Dr. Lori Davis and Dr. Ismene Petrakis

TONIX Pharmaceuticals

Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder and Comorbid PTSD – Dr. Lori Davis and Dr. Ismene Petrakis

BioXcel Therapeutics Inc

Effect of Sublingual formulation of Dexmedetomidine HCl (BXCL 501) on Ethanol in Healthy Humans and Heavy Drinkers – Dr. John Krystal and Dr. Ismene Petrakis

US World Meds

Lofexidine Combined with Buprenorphine for Reducing Symptoms of Post-Traumatic Stress Disorder and Opioid Use Relapse in Veterans – Dr. Christopher Verrico

Amygdala

An Aldehyde Dehydrogenase 2 Inhibitor for PTSD and AUD – Dr. Luba Yammine