2015 web - ctn dissemination libraryctndisseminationlibrary.org/pdf/webinar2015.pdf10-11 preparing...

National Drug Abuse Treatment Clinical Tr ia ls Network

CTN WEB SEMINAR SERIES: A FORUM TO

EXCHANGE RESEARCH KNOWLEDGE

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CTN Web Seminar Series: A Forum to Exchange Research Knowledge

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2015 WEB SEMINAR SERIES

Dear CTN Members Now in its seventh year, the CTN Web Seminar Series serves as a forum for CTN members to share and exchange clinical research knowledge. Building on previous years’ efforts as well as feedback from CTN membership, we have developed the 2015 series to address topics of particular relevance to CTN members. These topics address the conduct of clinical trials, treatment methodologies, publications management, regulatory compliance, and Good Clinical Practice guidelines. We thank our presenters, who graciously volunteer their time, knowledge, and expertise. Additionally, we thank the membership of the CTN for their participation on our webinars, which helps to create our CTN-wide learning environment. As always, your feedback is appreciated. Attendees will be given the opportunity to provide course-specific feedback after each webinar, and general feedback can always be directed through our CTN Training Suggestion Box at https://www.surveymonkey.com/s/CTNTrainingSuggestionBox. Please enjoy the 2015 training program. Tracee Williams Training Coordinator

This training has been funded in whole or in part with Federal funds from the National Instituteon Drug Abuse, National Institutes of Health, Department of Health and Human Services, under

Contract No. HHSN271201000024C.

CTN Web Seminar Series: A Forum to Exchange Research Knowledge WEB SEMINAR SERIES 2015

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2015 WEB SEMINAR SERIESTABLE OF CONTENTS

WEB SEMINAR PAGE #

Publications Planning and Preparation 4-5

Privacy and Confidentiality Protections for Research Participants with Substance Use Disorders 6-7

Medication Assisted Treatment for American Indians and Alaska Natives 8-9

GCP Refresher and GCP/GCDMP Trends in the CTN 10-11

Preparing for Closeout of Studies and Sites 12-14

Family Involvement in Substance Use Disorder and Mental Health Treatment and Research 15-16

Emotional Brain Training and Substance Use Disorders 17-18

Electronic Medical/Health Records – Common Data Elements for Substance Use Disorders 19-20

Concepts of CBT and Strengths-Based Approaches to Addiction and Mental Health Research and Treatment 21-22

Motivational Interviewing in Clinical Trials 23-24

Training Resources 25

ASI Lite Trainers 26


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PUBLICATIONS PLANNING AND PREPARATION

WEDNESDAY, JANUARY 281:00-2:00 PM (ET)

SEMINAR DESCRIPTION:As the CTN continues to conduct quality studies and report important results from substance use and mental health clinical investigations, it is important that study teams plan for effective dissemination of the scientific and clinical data collected. This one-hour webinar will provide guidance on publication planning and preparation. It will identify the types of papers that are produced, strategies for timely dissemination of methodologies and analyses, and elements of quality study reporting.

LEARNING OBJECTIVES:

■■ Describe what is a Publication Plan, the importance of an effective strategy, and when and how to incorporate it into a clinical investigation plan.

■■ Identify the various types of papers to produce from CTN study data and introduce other resources for sharing network data that contributes to analyses and publications.

■■ Discuss the role of the CTN Publications Committee and the process and materials needed for review.

■■ Discuss suggestions, based on experience of the Publications Committee, regarding ways to enhance the quality of CTN reports.

TARGET AUDIENCE:This webinar is targeted to all investigators, clinicians, statisticians, and other research staff engaged in the planning, development, and writing of research papers, publications, and presentations.

INSTRUCTORS:George Bigelow, PhD Dr. Bigelow is at the Johns Hopkins University School of Medicine in Baltimore, Maryland, where he is Professor and Director of the Behavioral Pharmacology Research Unit (BPRU), a multifaceted clinical research program specializing in studies of substance abuse


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and its treatment. His training is in experimental psychology and psychopharmacology. Since the CTN’s inception, he has been on the faculty of the CTN’s Mid-Atlantic Node and chair of the CTN’s Publications Committee. Dr Bigelow’s research interests and expertise in drug-abuse clinical research span many drug classes and include both human laboratory studies and outpatient therapeutic trials; special interests have been clinical pharmacology of drugs of abuse, pharmacotherapy development, and incentive-based approaches for motivating adherence and behavior change. He has authored or coauthored over 250 scientific papers, is a Fellow of numerous scientific organizations, and has received multiple honors for his work.

Dikla Blumberg, PhD

Dr. Blumberg is a Protocol Specialist for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Clinical Coordinating Center at The Emmes Corporation. She is a Social Psychologist with

expertise in self-regulation processes and over 10 years of experience in behavioral research. Previously, Dr. Blumberg worked in a NIDA-funded Postdoctoral Traineeship in Drug Abuse Treatment and Services Research at UCSF, where she designed and implemented a series of experiments investigating self-regulation processes involved with tobacco dependence. Additionally, she worked on a Cancer Research Training Award at the National Cancer Institute’s Behavioral Research Program, where she was involved with projects designed to better understand health behaviors and their underlying processes.

PUBLICATIONS PLANNING AND PREPARATION (CONT.)


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PRIVACY AND CONFIDENTIALITY PROTECTIONS FOR RESEARCH PARTICIPANTS WITH SUBSTANCE USE DISORDERS

NEW FEATURE TOPICDate and registration information will be provided when available.

SEMINAR DESCRIPTION:Maintaining the privacy and confidentiality of research participants is a critical aspect of conducting quality research investigations and reflects compliance with Good Clinical Practice guidelines and regulations. There are specific rules and protections established for nondisclosure of research and medical records of study participants with substance use disorders, the primary population enrolled in CTN studies. This one-hour course will acquaint attendeeswith 42 CFR Part 2 privacy protections and their applicability to substance abuse treatment and research.


■■ Describe the basic privacy protections afforded by 42 CFR Part 2.

■■ Understand what programs are covered and what information is protected.

■■ Consider the applicability of 42 CFR Part 2 as substance abuse treatment becomes increasingly available in general medical settings.

TARGET AUDIENCE:Everyone is welcome! This webinar is targeted for all staff engaged in the conduct of substance use treatment and research.

INSTRUCTORS:Maureen Boyle, PhD Dr. Maureen Boyle is the Chief of the Science Policy Branch in NIDA’s Office of Science Policy and Communications. Prior to joining NIDA, Dr. Boyle was a Lead Public Health Advisor for Health Information Technology (HIT) at the Substance Abuse

and Mental Health Services Administration (SAMHSA) where she coordinated efforts to promote the use of technology to improve the delivery of substance abuse treatment. Prior to joining SAMHSA Dr. Boyle was an American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellow serving at the National Institutes of Health, Office of Behavioral


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PRIVACY AND CONFIDENTIALITY PROTECTIONS FOR RESEARCH PARTICIPANTS WITH SUBSTANCE USE DISORDERS (CONT.)

and Social Sciences Research (OBSSR). In this role she led multiple initiatives to improve data collection and clinical quality measurement within behavioral health. Dr. Boyle received her PhD in neuroscience from Washington University in St. Louis where she studied the genetic and molecular basis of depression and anxiety-related behaviors. She completed a postdoctoral fellowship at the Allen Institute for Brain Science where she investigated neuropathological, molecular, and genetic abnormalities in Autistic children and animal models of autism.

Carmen Rosa, MS

Ms. Carmen Rosa works at the Center for Clinical Trials Network, within the National Institute on Drug Abuse (NIDA), National Institute of Health (NIH). She has been with NIDA since 1999, when NIDA started the National

Drug Abuse Treatment Clinical Trials Network (CTN). Since then, she has held several roles overseeing the Network’s research management and implementation. Currently, Ms. Rosa serves as Regulatory Officer at the CCTN providing regulatory consultations to investigators and NIDA staff. Her other major responsibilities include working with CTN staff and investigators in developing and implementing clinical trials, managing Protocol Review and Data and Safety Monitoring Boards that review and oversee various multi-site trials, coordinating the CTN international activities, and serving as an advocate for women and minority participation in research.


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MEDICATION ASSISTED TREATMENT FOR AMERICAN INDIANS AND ALASKA NATIVES

WEDNESDAY, FEBRUARY 1112:00 PM-1:00 PM (ET)

SEMINAR DESCRIPTION:Remarkable progress has been made in the development of medications to treat substance use disorders, yet consistent and widespread access to such medications remains low. This gap between patient need and actual implementation of efficacious treatment is especially troubling for vulnerable populations including American Indian and Alaska Natives (AI/AN). This course will provide an overview of organizational and provider characteristics influencing access to medication assisted treatments (MAT) for addictive disorders in AI/AN populations along with a review of results from a national survey of AI/AN substance abuse treatment program clinicians and clinical administrators regarding the incorporation of cultural, evidence-based concepts and healing techniques.


■■ Understand organizational and provider characteristics that affect access to medication assisted treatments for American Indian and Alaska Natives (AI/AN) dealing with addictive disorders.

■■ Consider implications for the design and implementation of treatment programs and services for vulnerable populations, including American Indian and Alaska Natives.

■■ Discuss significant aspects of a national study on AI/AN treatment programs.

TARGET AUDIENCE: This webinar is targeted to all research staff.

INSTRUCTORS:Traci Rieckmann, PhD, MS Dr. Traci Rieckmann is an Associate Professor in the School of Medicine, Department of Public Health & Preventive Medicine at Oregon Health & Science University and an Adjunct Associate Professor in the UCLA Department ofPsychiatry. She received her PhD in Counseling Psychology


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MEDICATION ASSISTED TREATMENT FOR AMERICAN INDIANS AND ALASKA NATIVES (CONT.)

from the University of Utah, Salt Lake City, and she holds a MS in Health Promotion as well. As a clinician, clinical and policy researcher, organizational change consultant and educator, Dr. Rieckmann’s work impacts multiple service delivery settings. Trained in both qualitative and quantitative methodologies, her specific research interests include acceleration of implementation of new practices including collaborative care models, technology-based interventions and medications to treat behavioral health and substance use disorders, organization and systems transformation, and quality improvement. Dr. Rieckmann’s current research projects are focused on clinical trials for patients with addictions, disparities in care for American Indian/Alaska Native clients, and assessment of counselor and organizational attributes that drive uptake of evidence-based practices in substance abuse treatment, particularly medication-assisted treatment for opioid and alcohol dependence. Dr. Rieckmann is currently the Principal Investigator of the Northwest Addiction Technology Transfer Center, a behavioral health workforce capacity SAMHSA-funded entity. She is also co-investigator on two NIH-funded studies; one examining the impact of the implementation of Coordinated Care Organizations in Oregon on treatment for alcohol and drug use disorders, and a second NIH-funded study on the use of Buprenorphine to improve HIV care engagement and outcomes in Vietnam. Dr. Rieckmann has over 50 peer-reviewed publications, and presents on a regular basis at national and local conferences, and has provided legislative testimony regarding substance abuse policy in the state of Oregon. She is active in her local community and enjoys running, cycling and outdoor activities with her family and friends.

Lisa Rey Thomas, PhD

Dr. Lisa Rey Thomas is the Director of the Suquamish Tribe Wellness Center and a Research Scientist at the University of Washington’s Alcohol and Drug Abuse Institute. Dr. Thomas’ focus is community-based

participatory research with American Indian and Alaska Native (AI/AN) communities to reduce health disparities and promote health and wellness in a culturally appropriate and strengths based manner. She is particularly interested in access to appropriate care for mental health and substance misuse for AI/AN individuals, families, and communities.


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GCP REFRESHER AND GCP/GCDMP TRENDS IN THE CTN

WEDNESDAY, MARCH 1812:00 PM-1:30 PM (ET)

SEMINAR DESCRIPTION:Good Clinical Practice guidelines provide ethical and scientific standards for the design, quality assurance, data collection, analyses, and reporting for clinical trials. GCP standards ensure that research staff protect the rights, safety, well-being, and confidentiality of trial participants as well as comply with best practices in their conduct of clinical investigations. This 90-minutepresentation will focus on the critical aspects of ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials. Additionally, there will be discussion on Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP) trends in the CTN.


■■ Review principles and regulatory requirements for GCP.

■■ Discuss staff roles and responsibilities, protocol compliance, and other criteria for conducting quality trials.

■■ Examine best practices, examples of GCP non-compliance, and corrective actions for protocol or procedural deviations.

■■ Identify significant GCP/GCDMP trends in the CTN, such as informed consent, safety, documentation, drug management, and data management.


INSTRUCTORS:Denise King, MS, RD, CCRA Ms. King is the Project Manager for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Clinical Coordinating Center at The Emmes Corporation. She has over 13 years of clinical trial experience and over

seven years experience overseeing the operational, data management, regulatory, monitoring and protocol development processes for multi-


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GCP REFRESHER AND GCP/GCDMP TRENDS IN THE CTN (CONT.)

protocol, multi-phase projects in a variety of disease and therapeutic areas. Ms. King has been a member of the Internal Quality Assurance Audit Team at The Emmes Corporation for over three years. Ms. King received a Bachelor of Science Degree in Nutritional Sciences from Cornell University and a Master of Science Degree in Nutrition and Exercise Science at the State University at Buffalo.

Lauren Yesko, BS

Lauren Yesko serves as the Lead Data Manager for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Data and Statistics Center at The Emmes Corporation . She has over eight years of experience

managing large, multi-center clinical trials. Lauren has provided Data Management support on a number of CTN protocols, including CTN-0047 SMART-ED, CTN-0048 CURB, CTN-0052 BRAC, CTN-0059 TAPS, and continues to support other current CTN studies. In addition to her work for the CTN, she serves as the Lead Data Manager for the SCORE2 protocol funded by the NEI, evaluating treatments for Retinal Vein Occlusion. Previously, she provided project management support to a number of pre-clinical and Phase II clinical cardiovascular device trials. She received a Bachelor of Science from the University of Michigan.


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PREPARING FOR CLOSEOUT OF STUDIES AND SITES

WEDNESDAY, APRIL 2912:00 PM-1:30 PM (ET)

SEMINAR DESCRIPTION:Proper closeout of a multisite clinical trial is as important as the implementation process, both phases require adequate preparation for timely and efficient conduct. In the CTN, study closeout involves careful logistical coordination among key stakeholders and role groups, such as the Sponsor, Lead Node, local nodes, research sites, Clinical Coordinating Center, Data and Statistics Center, and vendors. This 90-minute presentation will review the essential aspects of study and site closeout for clinical trials, by discussing shared activities as well as other supportive tasks.


■■ Discuss planning for trial closeout, and identify critical activities that make for timely and efficient closeout.

■■ Define roles and responsibilities, regulatory obligations, documentation requirements, and other processes to consider at the end of a study.

■■ Review lessons learned in the closeout of other CTN studies.

TARGET AUDIENCE: Everyone is welcome! This training is targeted to all research staff engaged in closeout activities for studies and sites and those interested in learning what to expect at study closeout.

INSTRUCTORS:Christie Thomas, MPH Ms. Thomas has over 17 years of clinical research experience conducting trials for substance abusing populations, including 12 years of work in the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN), Pacific Region Node based in Los Angeles,

California. She has contributed to the work of the CTN in various supportive and management roles and at virtually every stage, including protocol development, trial conduct, closeout, and the reporting of study findings.


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PREPARING FOR CLOSEOUT OF STUDIES AND SITES (CONT.)

Previously, Christie served as National Project Director or Co-Director of CTN-0003, 0027, and 0048. Currently, she is the National Project Director for CTN-0054, Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT). Under the leadership of Drs. Walter Ling and Larissa Mooney, Christie directs national study activities to ensure successful study implementation and regulatory compliance. Ms. Thomas holds a Masters degree in Public Health and a Bachelor of Arts degree in Psychology from the University of California. She is a member of the Association of Clinical Research Professionals (ACRP) and Regulatory Affairs Professionals Society (RAPS), and has received dual certification from ACRP as a Certified Clinical Research Coordinator (CCRC) and Certified Clinical Research Associate (CCRA).

Matthew Wright, BS

Matthew Wright is a Protocol Specialist for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Clinical Coordinating Center at The Emmes Corporation . He has over eight years of clinical trial experience and over two years experience managing

large, multi-site projects for the NDAT CTN. He has provided oversight in the operational, regulatory, monitoring, and protocol development processes for multiple CTN trials, including CTN-0048 (CURB), CTN-0049 (Project HOPE), CTN-0052 (BRAC), and CTN-0053 (ACCENT), among others. Previously, Mr. Wright served as a Clinical Research Coordinator at the Collaborative Neuroscience Network in Los Angeles, California, providing support for Phase I-IV clinical trials investigating a variety of psychiatric and neurological disorders. Mr. Wright obtained a BS degree from Virginia Tech.


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PREPARING FOR CLOSEOUT OF STUDIES AND SITES (CONT.)

Dikla Blumberg, PhD

Dr. Blumberg is a Protocol Specialist for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Clinical Coordinating Center at The Emmes Corporation. She is a Social Psychologist with expertise in self-regulation processes and over 10 years of experience in behavioral

research. Previously, Dr. Blumberg worked in a NIDA-funded Postdoctoral Traineeship in Drug Abuse Treatment and Services Research at UCSF, where she designed and implemented a series of experiments investigating self-regulation processes involved with tobacco dependence. Additionally, she worked on a Cancer Research Training Award at the National Cancer Institute’s Behavioral Research Program, where she was involved with projects designed to better understand health behaviors and their underlying processes.


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FAMILY INVOLVEMENT IN SUBSTANCE USE DISORDER AND MENTAL HEALTH TREATMENT AND RESEARCH

WEDNESDAY, MAY 271:00-2:00 PM (ET)

SEMINAR DESCRIPTION:Substance use disorders (SUDs) not only have an impact on the affected individual, but also on the family unit, individual members (including children), and other significant relationships. This one-hour presentation will review the impact of SUDs on the family system and its members as well as address how family involvement improves client outcomes and satisfaction rates. Strategies to help individuals in treatment address family issues will be discussed as well as strategies to include the family in treatment. Family treatment interventions will be reviewed briefly, with an emphasis on recovery and wellness for family members.


■■ Identify the impact of SUDs on families and their members.

■■ Review strategies for the patient in treatment to address family issues.

■■ Review clinical interventions to help families.


INSTRUCTORS:Dennis Daley, PhD, LSW Dr. Daley is a professor of psychiatry and social work at the University of Pittsburgh Medical Center. He previously served for 14 years as Chief of Addiction Medicine Services in the Department of Psychiatry at Western Psychiatric

Institute and Clinic. He is the Principal Investigator of the CTN Appalachian Tri-State Node and has been an investigator on both NIDA and NIAAA sponsored studies. Dennis has created numerous publications, videos, and educational materials on substance use, psychiatric, co-occurring disorders, family issues and relapse. His treatment manuals and recovery materials are


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FAMILY INVOLVEMENT IN SUBSTANCE USE DISORDER AND MENTAL HEALTH TREATMENT AND RESEARCH (CONT.) used in many programs in the U.S. and other countries, and several of his books and recovery guides have been translated to foreign languages. Dennis contributes regular columns on behavioral health and recovery issues to the Counselor Magazine for professionals, and the Counselor Connection.

John Hamilton, LMFT, LADC, CAC-E

John Hamilton has worked in the field of addiction prevention and treatment since 1981, and holds licenses in Alcohol and Drug Counseling and Marriage and Family Therapy. Mr. Hamilton is the CEO for Recovery Network of Programs, a non-profit behavioral health agency

serving the Greater Bridgeport community. Currently, John is on the Steering Committee for the NDAT CTN and is the Chair of the Policy Committee for the Community Treatment Providers Caucus. John is the Chair of the Connecticut State Advisory Board for the Department of Mental Health and Addiction Services (DMHAS) and Board Member for the Connecticut Community for Addiction Recovery (CCAR). Previously, John served as Chair of the Dissemination Committee for the NDAT Clinical Trials Network, Chair of the Community Treatment Providers Caucus, Past President of the Southwest Connecticut Mental Health Board, Past President of the New England Association of Drug Court Professionals, Co-founder of the Greenwich Father’s Forum, and Chair of the Ethics Committee for the Connecticut Certification Board. John presents locally and internationally on a variety of topics and is considered an expert in the field of addiction treatment and prevention. John was the 2013 recipient of the American Association for the Treatment of Opioid Dependence (AATOD) Nyswander-Dole Award for his outstanding contributions in the field of Addiction Treatment.


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EMOTIONAL BRAIN TRAINING AND SUBSTANCE USE DISORDERS

WEDNESDAY, JUNE 101:00-2:00 PM (ET)

SEMINAR DESCRIPTION:Emotional brain training (EBT) uses a brain-based structured system to promote self-directed neuroplasticity of the circuitry that promotes allostatic states and addictive behaviors. The method integrates training in tools to encode emotional resiliency circuitry and to reconsolidate allostatic circuits that activate and prolong addictive behaviors. In addition, EBT uses an ITdelivery platform that facilitates effective small group teleconferencing for learning EBT and confidential peer-to-peer support between session. This one-hour presentation will explain what is EBT, discuss the science behind it, and identify methods used for delivering and researching EBT.


■■ Define emotional brain training and discuss the science behind it.

■■ Explain implications of EBT on addiction and extreme behaviors.

■■ Discuss EBT methods for IT-based, professionally-facilitated delivery and research.


INSTRUCTORS:Laurel M. Mellin, PhD Laurel Mellin, PhD, is a health psychologist and an associate professor of family and community medicine and pediatrics at the University of California, San Francisco (UCSF). She is the founder of emotional brain training

(EBT), a method of rewiring the emotional brain to decrease allostatic load as an emerging brain-based paradigm in health. The method is an integration of neuroscience, attachment theory, evolutionary biology, and stress physiology. She collaborates with researchers at UCSF as well as with researchers at Weill-Cornell Medical College in exploring interventions for underserved


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EMOTIONAL BRAIN TRAINING AND SUBSTANCE USE DISORDERS (CONT.)

populations and stress-related problems. She directs The Solution Foundation, a non-profit organization promotes awareness of training the emotional brain. Her research interests include stress, allostatic load, addictions, obesity, depression, and the treatment of stress related conditions, with particular emphasis on the underserved.

Dikla Blumberg, PhD

Dr. Blumberg is a Protocol Specialist for the National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Clinical Coordinating Center at The Emmes Corporation. She is a Social Psychologist with expertise in self-regulation processes and over 10 years of experience in behavioral research. Previously, Dr. Blumberg worked

in a NIDA-funded Postdoctoral Traineeship in Drug Abuse Treatment and Services Research at UCSF, where she designed and implemented a series of experiments investigating self-regulation processes involved with tobacco dependence. Additionally, she worked on a Cancer Research Training Award at the National Cancer Institute’s Behavioral Research Program, where she was involved with projects designed to better understand health behaviors and their underlying processes.


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ELECTRONIC MEDICAL/HEALTH RECORDS – COMMON DATA ELEMENTS FOR SUBSTANCE USE DISORDERS

WEDNESDAY, JULY 812:00 – 1:00 PM (ET)

SEMINAR DESCRIPTION:Electronic Medical Records (eMedical Records/EMR) and Electronic Health Records (EHR) are becoming more and more significant in the delivery of quality healthcare. These EMR and EHR systems are designed based on critical data elements commonly used for collection of medical history and made available in clinical care as well as in research. This one-hour webinar will discuss the differences between EMRs and EHRs, Common Data Elements (CDEs), and implications for use in research projects on Substance Use Disorders.


■■ Define differences between eMedical Records/EMRs and EHRs.

■■ Explain use of CDEs in clinical care and clinical research.

■■ Outline the role of CDEs for Substance Use Disorders in an integrated vision of clinical care and research.

TARGET AUDIENCE: Everyone is welcome! This webinar is targeted to all investigators, clinical, and research staff, and statistical staff interested in learning more on common data elements of electronic medical and health records.

INSTRUCTORS:Robert Gore-Langton, PhD Dr. Gore-Langton is a Project Leader and Principal Investigator on multiple NIH-sponsored projects at The Emmes Corporation and has been serving as an advisor to the National Drug Abuse Treatment Clinical Trials Network

(NDAT CTN) Data and Statistics Center since 2010. In this role, he is leading development of Common Data Elements (CDEs) for Substance Use Disorders for use in Electronic Health Records and clinical research, and overseeing the development of an electronic Clinical Quality Measure (eCQM) for tobacco,


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ELECTRONIC MEDICAL/HEALTH RECORDS – COMMON DATA ELEMENTS FOR SUBSTANCE USE DISORDERS (CONT.)

alcohol, and illicit drug use and prescription drug misuse. He received his PhD in physiology from the University of Cambridge and was a Charles H. Best postdoctoral fellow at the University of Toronto. He has held faculty appointments at the University of Western Ontario while concurrently an Ontario Ministry of Health Career Scientist, Associate Scientist in the Robarts Research Institute and Department Manager at University Hospital in London, Ontario and as Associate Professor in the Department of Pediatrics at Georgetown University School of Medicine. His work has frequently spanned the gap behind research and clinical practice and involved biomedical informatics.

Betty Tai, PhD

Dr. Tai has served as the director of the National Institute on Drug Abuse’s (NIDA’s) Clinical Trials Network (CTN) Program since her appointment in 1999. The CTN Program is intended to bridge the gap between research and practice, rapidly translate research to patient care, and

raise the drug abuse treatment standard. Dr. Tai has received awards including Research Service Awards from the American Psychological Association and the J. Michael Morrison Award from the College on Problems of Drug Dependence in recognition of her outstanding contributions in the area of scientific administration related to treatment of drugs of abuse. Dr. Tai received a MS from the University of Massachusetts, a PhD from the George Washington University, and postdoctoral training from the laboratory of neuroscience at National Institute on Aging. She joined NIDA in 1989 and became an extramural program administrator directing clinical research programs for the development of anti-drug-abuse medications.


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CONCEPTS OF CBT AND STRENGTHS-BASED APPROACHES TO ADDICTION AND MENTAL HEALTH RESEARCH AND TREATMENT

WEDNESDAY, AUGUST 121:00 – 2:00 PM (ET)

SEMINAR DESCRIPTION:In the CTN, investigators and research staff engage in the conduct of studies and treatment for patients dealing with substance use and mental health disorders. There are a number of interventions and approaches used for relapse prevention and recovery, including coaching and counseling for lifestyle and behavioral modifications. This one-hour webinar will discussCognitive-Behavioral Treatment and strengths-based approaches as interventions to prevent relapse and sustain recovery in treatment and research settings.


■■ Provide a brief introduction and overview of CBT as it is utilized in substance use and mental health disorders.

■■ Introduce the Dysfunctional Thought Record and discuss how this can be utilized with substance use and mental health disorders.

■■ Describe the use of structure in CBT.

■■ Outline a CBT session.

TARGET AUDIENCE: Everyone is welcome! This webinar is targeted to experienced investigators and clinical research professionals involved in the treatment and research of individuals with substance use and mental health disorders.

INSTRUCTORS:Suzette Glasner-Edwards, PhD Dr. Glasner-Edwards is a licensed clinical psychologist and a Principal Investigator at UCLA Integrated Substance Abuse Programs. She earned her BA in psychology from UCLA and her PhD in psychology at the University of Minnesota.

Subsequently she completed her post-doctoral training at UCSD and the San Diego VA in the study and practice of psychotherapy for addictions.


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CONCEPTS OF CBT AND STRENGTHS-BASED APPROACHES TO ADDICTION AND MENTAL HEALTH RESEARCH AND TREATMENT (CONT.)

Dr. Glasner-Edwards has extensive clinical and research background in the use of cognitive-behavioral, motivational, and mindfulness-based interventions for adults who have substance use disorders with and without concurrent mental illness. Dr. Glasner-Edwards teaches these therapy techniques to psychiatry residents and psychologists in post-doctoral training at UCLA. A recipient of a career development award from NIDA, Dr. Glasner-Edwards’ current research focuses on developing technology-assisted psychosocial interventions and evaluating treatment outcomes for drug abusing adults with co-occuring psychiatric illness (with a particular focus on depression). She has also conducted research on pharmacological treatments for stimulant users with depression.

Albert L. Hasson, MSW

Mr. Hasson has worked in the field of addiction medicine as a researcher and a treatment provider since 1977. He began his career as a research associate at the Sepulveda Veterans Affairs Drug Dependence Treatment Center in Los Angeles, implementing research on the use of naltrexone

and levo-alpha-acetylmethadol (LAAM) for the treatment of opioid addiction. After receiving his Masters of Social Welfare from the University of California, Los Angeles, Mr. Hasson served as a regional director for Community Health Projects (CHP), Inc., the largest provider of pharmacotherapy (methadone and naltrexone) for opioid addiction in California. From 1989 until June 2003, Mr. Hasson was an Administrative Director of the Matrix Institute on Addictions, where he established four community-based intensive outpatient treatment programs, including the Matrix Opioid Treatment Program in Los Angeles. Mr. Hasson served as Chairman of the Matrix Institute Board of Directors from 1993 through 2005. He has extensive experience in cognitive behavioral therapy (CBT) providing CBT-based counseling to patients, conducting research on CBT for SUDs, and training counselors and clinical staff in CBT practices for SUDs. For the past ten years, Mr. Hasson has worked as a Project Director under the direction of Drs. Walter Ling and Richard A. Rawson, and as the Node Coordinator for the Pacific Region Node of the NDAT Clinical Trials Network at the UCLA Integrated Substance Abuse Programs.


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MOTIVATIONAL INTERVIEWING IN CLINICAL TRIALS

WEDNESDAY, SEPTEMBER 1612:00 PM - 1:00 PM (ET)

SEMINAR DESCRIPTION:Motivational Interviewing (MI) is an empirically supported treatment for substance use disorders and a variety of other problematic behaviors. Over three decades of research have established the clinical effectiveness of MI and some of its mechanisms of action. This webinar will describe what MI is, how it works, MI consistent and inconsistent practices, standards of performance, clinician qualifications, and available training resources. The presentation is meant to provide a broad overview of MI and whet the appetites of participants to pursue further education and training in this treatment approach.


■■ Understand four key characteristics of MI Spirit.

■■ Review four main therapeutic processes involved in MI.

■■ Identify key strategies that build relationships with clients and elicit their motives for change.

TARGET AUDIENCE: Everyone is welcome! This webinar is targeted to clinical and research staff interested in receiving an introduction to Motivational Interviewing.

INSTRUCTORS:Steve Martino, PhD Steve Martino received his PhD in Clinical Psychology from DePaul University in 1990. He is a Professor of Psychiatry within the Psychology Section at the Yale University School of Medicine and Chief of the Psychology Service at the VA

Connecticut Healthcare System. He specializes in the treatment of addictive disorders and of patients diagnosed with co-occurring psychiatric problems, with specific interests in motivational interviewing, cognitive behavioral therapy, group work, use of brief interventions, and clinical supervision. His current research focuses on strategies for disseminating and implementing


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MOTIVATIONAL INTERVIEWING IN CLINICAL TRIALS (CONT.)

motivational interviewing in community treatment programs and medical settings.

Theresa Moyers, PhD

Theresa Moyers is an Associate Professor of Psychology at the University of New Mexico. Her research focuses on identifying active ingredients of behavioral treatments for addictive disorders, including client language within motivational interviewing. She has been involved in

three randomized, controlled trials to identify optimal methods for teaching motivational interviewing to frontline substance abuse providers.


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TRAINING RESOURCES

DID YOU MISS A WEB SEMINAR? All seminar recordings, presentations, and training materials are available on the CTN Dissemination Library’s training website at http://www.ctndisseminationlibrary.org/ctntraining.htm.

GOOD CLINICAL PRACTICE TRAININGGCP training prepares study staff responsible for critical aspects ofstudy conduct. Per CTN Policies and Procedures, all study staff isrequired to complete such training, subject to renewal every three (3)years. Reference the CTN GCP Online training website here:https://gcp.nihtraining.com.

PROTECTING HUMAN RESEARCH PARTICIPANTSThis two-hour web-based course is designed for conducting research and presents information on the rights and welfare of human research participants. It satisfies the NIH human subjects training requirement for obtaining federal funds, subject to renewal every three (3) years. A certificate is available upon completion: http://phrp.nihtraining.com.

DEMOGRAPHICSThe training is available on http://ctndisseminationlibrary.org ctntraining.htm. Requests for quiz grading and completion certificates may be directed to [email protected].

CONTINUING EDUCATION (CEU) RESOURCEFor continuing education credits, reference the Society of Clinical Research Associates (SoCRA) website here: http://www.socra.org/html/certific.htm.

OPPORTUNITY FOR FEEDBACKWe want to hear from you. Do you have a question, comments, or a suggestion for CTN Training? Please use our CTN Training Suggestion Box to provide your general feedback or to submit comments:https://www.surveymonkey.com/s/CTNTrainingSuggestionBox.


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DO YOU NEED TRAINING?Contact us at [email protected] to arrange for a trainer.

ASI LITE TRAINERS

Node Affiliation/Trainer LOCATION21-Delaware Valley (DV)

Charlotte Royer-Malvestuto* Philadelphia, PA

Sabrina Poole* Philadelphia, PA

23-Greater New York (GNY)

Aimee Campbell New York, NY

Megan Ghiroli New York, NY

24-Mid-Atlantic (MA)

Dace Svikis Richmond, VA

26-Ohio Valley (OV)

Frankie Kropp Cincinnati, OH

27-Pacific Northwest (PNW)

Ron Jackson* Seattle, WA

Katherine Michelle Peavy Seattle, WA

Sharon Garrett Seattle, WA

Michelle Ingalsbe Seattle, WA

Mary Hatch-Maillette Seattle, WA

28-Pacific Region (PA)

Mark Oyama Los Angeles, CA

Thomas Freese Los Angeles, CA

Beth Rutkowski Los Angeles, CA

29-Southern Consortium (SC)

Susan Sonne Charleston, SC

Therese Killeen Charleston, SC

30-Southwest (SW)

Roberta Chavez Albuquerque, NM

* Indicates Master Trainer


THE EMMES CORPORATION 401 N. WASHINGTON ST., SUITE 700ROCKVILLE, MD 20850301-251-1161

NDAT CTN Clinical Coordinating Center (CCC)E-MAIL:Inquiries or Supplies. . . . . . . . . . . . [email protected] Documents . . . . . . . . . [email protected] Related Events. . . . . . . . . . . [email protected] Inquiries . . . . . . . . . . . . . . [email protected] Fax Number . . . . . . . . . . . . . 301-576-3924

THE CLINICAL COORDINATING CENTER CAN COORDINATE TRAINING OR PROVIDE TRAINING MATERIAL AS NEEDED FOR THE FOLLOWING:

■■ Addiction Severity Index (ASI)■■ Composite International Diagnostic Interview (CIDI) v2.1■■ Risk Behavior Survey (RBS)

Please contact [email protected].

NDAT CTN Data and Statistics Center (DSC)Group E-mail [email protected] Fax Number . . . . . . . . . . . . . 800-416-2017

Website URL . . . . . . . . . . . . . . . . . . www.ctndsc2.com

DSC HELP DESK CONTACT INFORMATIONMonday-Friday (8:00 a.m. to 8:00 p.m. ET)Help Desk . . . . . . . . . . . . . . . . . . . . 888-337-7071 (toll-free)Help Desk E-mail . . . . . . . . . . . . . . [email protected] ID Request Form is located on the DSC 2 (Emmes) page on Livelink.

Other Help Desk Support

■■ Request access to Livelink■■ Request access to CTN Clinical Trials Report Website■■ AdvantageEDC issues/inquiries■■ Protocol-specific inquiries■■ Protocol-specific system issues/inquiries

WEB SEMINAR 2015

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INSIDE THE 2015 WEB SEMINAR SERIES

COURSE TITLE DATE

Publications Planning and Preparation JAN 28

Privacy and Confidentiality Protections for Research Participants with Substance Use Disorders

TBD*

Medication Assisted Treatment for American Indians and Alaska Natives

FEB 11

GCP Refresher and GCP/GCDMP Trends in the CTN

MAR 18

Preparing for Closeout of Studies and Sites APR 29

Family Involvement in Substance Use Disorder and Mental Health Treatment and Research MAY 27

Emotional Brain Training and Substance Use Disorders JUN 10

Electronic Medical/Health Records – Common Data Elements for Substance Use Disorders

JUL 8

Concepts of CBT and Strengths-Based Approaches to Addiction and Mental Health Research and Treatment AUG 12

Motivational Interviewing in Clinical Trials SEP 16

*TBD – To Be Determined