Participating Organizations

Baylor College of Medicine, Houston, Texas

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

Medical University of South Carolina, Charleston, South Carolina

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/

University of Houston, Houston, Texas

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/

Tuscaloosa Research & Education Advancement Corporation (TREAC)/Tuscaloosa VA Medical Center (TVAMC)

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

Connecticut Research & Education Foundation (CREEF) / VA Connecticut Healthcare System (VACT)

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.

University of San Diego, San Diego, California

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/

Pharmaceutical Collaborations

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