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This 90-minute session featured a range of presenters talking about peer support and intervention. [View agenda.]
Presentations included:
- A Primer on Peer Helpers and Addiction: Keith Humphreys, PhD [download slides]
- Peer Intervention to Link Overdose Survivors to Treatment (PILOT, CTN-0107): Kelly Barth, DO [download slides]
- HIV Prevention Trials Network 094 Study INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit: Steve Shoptaw, PhD [download slides]
- Oregon HOPE: A Community Peer Recovery Support Specialist Model for Engaging Rural People Who Use Drugs – P. Todd Korthuis, MD, MPH [download slides]
The session ended with a panel discussion featuring Dr. Korthuis as well as Pete Smith, Joanna Cooper, and Louise Haynes, MSW.
Related protocols: CTN-0107
This is the second session in a series titled “Research 101,” which will provide basic education about doing clinical research.
This webinar outlines the basics of FDA oversight and reviews other essential regulatory activities to successfully keep a study in compliance, including ongoing management and reporting requirements. The regulatory portion reviews essential regulatory activities, such as IRB approvals and informed consent requirements. Lastly, there is a discussion of current challenges and best practices when working on regulatory compliance.
This is the first session in a series titled “Research 101,” which will provide basic education about doing clinical research.
As some are new to clinical research, it is important to understand clinical trials, how they are conducted and the roles, responsibilities, participants, and procedures that are involved. For this first presentation in the Research 101 series, there will be a review of the different types of research, study designs, phases, and other key aspects of conducting human subjects research.
Approximately 40% of participants enrolled in CTN studies are women. Yet, women face unique issues when it comes to getting help with substance use disorder. It can be especially difficult for women to receive assistance for substance use disorder during or after pregnancy and when navigating the criminal justice system due to social stigma, legal issues, or other barriers.
The CTN prioritizes enrollment of women and minorities in research studies and recognizes the issues related to their participation. Accordingly, this 60-minute web seminar will consider the unique challenges that women face in the criminal justice system while struggling with substance use disorder. This will help research teams have a better understanding of the experience of women, including those that are pregnant and in the criminal justice system, and help researchers manage study retention and follow-up more effectively.
Presenters: Ank Nijhawan, MD, MPH (UT Southwestern Medical Center, Dallas, TX), Jaimie Meyer, MD, MS, FACP (Yale University, New Haven, CT), Mishka Terplan, MD, MPH, FACOG, DFASAM (Friends Research Institute, Baltimore, MD)
Learning Objectives:
- Describe the background and treatment of women with substance use in the criminal justice system.
- Discuss unique challenges of women in the criminal justice system, including considerations for pregnant women.
- Consider how this impacts research participation for women who use substances and pregnant women who use substances.
In this session, representatives from the Office for Human Research Protections (OHRP) will discuss relevant Common Rule requirements and what goes into a meaningful informed consent for research involving participants with substance use disorders.
Learning Objectives:
- Explain why getting meaningful consent is critical to enrolling research participants.
- Describe relevant Common Rule requirements for substance abuse research.
- Describe some of the important components for a meaningful consent.
Presented to the CTN Steering Committee, this webinar offers a 40 year retrospective of Dr. Stitzer’s career in addiction research. Includes the following sections:
- Part 1: Opioid physical dependence
- Part 2: Opioid treatment medication studies
- Part 3: Contingency management (CM)
- Part 4: Future directions summary
During the conduct of clinical trials, some participants may be lost to incarceration. In the National Drug Abuse Treatment Clinical Trials Network (CTN) particularly, researchers must anticipate prisoner involvement as the study population is susceptible to run-ins with the judicial system. This 90-minute web seminar—divided into five separate recordings–will consider strategies and tools that help research teams prepare prior to the start of a study and coordinate procedures during the study to effectively locate and retain participants lost to incarceration. Topics covered include the following:
Introduction to Prisoner Engagement in Clinical Trials. Dagmar Salazar, MS, CCC Protocol Specialist.
Download handout | Watch video
This introduction provides background on the inclusion of prisoners in clinical research and in relation to the National Drug Abuse Treatment Clinical Trials Network. Additionally, the presenter briefly introduces the tools and strategies that will be addressed in the following presentations.
Prisoner Engagement in Clinical Trials–Considerations for
Study Planning and Pre-Implementation. Sarah Farkas, MA, GNY Node.
Download handout | Watch video
This presentation will address considerations for investigators and their study teams when planning for prisoner involvement in CTN trials and introduce a helpful checklist tool with relevant, critical milestones to address during study pre-implementation.
Developing an Effective Standard Operating Procedure (SOP) for Research Staff Engagement with Participants Lost to Incarceration. Dagmar Salazar, MS, CCC Protocol Specialist.
Download handout | Watch video
This presentation will review the development of an effective SOP outlining procedures for prisoner involvement and management of research staff interactions with incarcerated participants and individuals affiliated with detention facilities.
Locating Participants Lost to Incarceration. Amber Regis, BA, GNY Node.
Download handout | Watch video
This presentation will discuss locating and monitoring participants within the criminal justice system, the importance of utilizing national and local resources in those efforts, and strategies for facilitating contact with incarcerated participants.
You’ve Located an Incarcerated Participant–What’s Next? Peter Greco, MPH, GNY Node.
Download handout | Watch video
This presentation will review how to gain access to a correctional facility, coordinating logistical details of the visit, protecting participant confidentiality, and tips for navigating safely and ethically within a correctional facility setting.
This web seminar series had three components:
Introduction to Retention in the NDAT CTN. Presented by Dikla Blumberg, PhD (NDAT CTN Clinical Coordinating Center):
Recruitment and retention are vital aspects of clinical research trials and can factor into the success of a study. Therefore, it is important that researchers understand and identify barriers to meeting recruitment and retention targets and the consequences experienced with poor retention. Additionally, it is helpful to examine historical data available on study retention trends to inform implementation efforts on future studies. Accordingly, this presentation briefly addresses these areas by providing an overview on the topic of study retention, retention within the context of the CTN, and discusses the importance of incorporating strategies and tools for study success.
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The “CHEERS” Principle of Participant Retention: More Than Just Techniques. Presented by Frankie Kropp, MS (OV Node) and Mitra Lewis, MS (NDAT CTN CCC):
Good participant retention involves more than just specific techniques; retention depends on the study staff’s overall philosophy of managing and accommodating study participants. One helpful way to think about participant retention is to insert the “CHEERS” principle into study retention efforts– Customer service, Help overcome barriers, Environment, Excellence, Relationship/Respect, and Search. This 20-minute webinar will provide an overview of the CHEERS principle, including specific examples of what sites can do to maximize participant retention.
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Utilizing a Robust and Comprehensive Locator Form as a Retention Tool. Presented by Phoebe Gauthier, MA, MPH (NE Node) and Dagmar Salazar, MS (NDAT CTN CCC).
Participant recruitment and retention are critical aspects of conducting quality clinical research projects. The National Drug Abuse Treatment Clinical Trials Network (NDAT CTN), which evaluates behavioral, pharmacological, and integrated treatment interventions for substance use disorders, routinely enrolls participants who may be challenging to locate during the treatment and follow-up phase of a trial. This 20-minute presentation will review one tool for increasing retention—an adapted locator form. This locator form is designed to better facilitate locating participants, especially those with unstable living conditions or with limited contact information. Additionally, this presentation will discuss the form elements beyond conventional locator forms and methods for collecting the information to help increase participant retention.
An Institutional Review Board (IRB) provides ethical review of proposed and ongoing clinical research to ensure the rights and welfare of research participants are protected, and that both the study and investigative team adhere to pertinent regulations governing the conduct of clinical trials. Clinical sites wishing to engage in human subjects research must be paired with an IRB registered with the Office of Human Research Protections, thereby ensuring adherence to all tenets of Good Clinical Practice. This pledge is provided in the form of a Federalwide Assurance (FWA) and is one of the central pillars of a clinical trial. This presentation from Eric Hardter, PhD, RAC, Regulatory Affairs Specialist at the NDAT Clinical Coordinating Center, Emmes Corporation, provides an overview of the basis of and need for a FWA as well as the roles and expectations of key stakeholders, including IRBs, institutions, and researchers involved in clinical studies.
Learning Objectives:
- Describe FWAs and FWA provisions.
- Discuss who needs to obtain FWAs, when, and who is covered.
- Consider the expectations and roles for IRBs, institutions, investigators, and researchers that provide oversight and/or engage in clinical research.
New regulations have established the expectation of a single Institutional Review Board (sIRB) to provide ethical review of a clinical research study. The measure is designed to maintain appropriate protection of study participants and yet streamline federally-funded research reviews by eliminating redundancy and avoiding unnecessary administrative burden. Accordingly, CTN researchers must understand the considerations to factor into selecting a sIRB for a multi-center study.
This presentation from Julia Collins, MD, Protocol Specialist at the NDAT Clinical Coordinating Center at the Emmes Corporation, will describe such considerations based on experiences and lessons learned from research teams working with a variety of sIRBs on seven CTN clinical studies.
Learning Objectives:
- Describe types of sIRBs and evaluate suitability for ethical reviews of specific trials.
- Define sIRB selection criteria as applied to studies across disease areas and study designs.
- Discuss other factors to consider and effective processes to implement when selecting a sIRB.
The CTN webinar “A Practical Guide to Using Brief Addiction Monitor Data in the VA,” was presented by Drs. Dominick DePhilippis and Eric J. Hawkins on August 14, 2017 at 12pm ET.
The Brief Addiction Monitor (BAM) is a tool to support measurement-based care for people with substance use disorders, that was originally developed to assess patient “outcomes” in a valid and efficient manner at the VA. This one-hour webinar looks at its development and features, clinical use of the BAM, programmatic use of the BAM, and implementation history of the BAM at the VA.
Dominick DePhilippis, PhD is the education coordinator for the CESATE at the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania. He also is a clinical associate in the Department of Psychiatry at the University of Pennsylvania’s Perelman School of Medicine. His areas of professional interest include the dissemination and implementation of measurement-based care and evidence-based treatments, in particular, motivational enhancement therapy and contingency management, in specialty care settings for patients with substance use disorders. He received his PhD in clinical psychology from Hahnemann University.
Eric J. Hawkins, PhD is an Investigator with Health Services Research & Development (HSR&D) Seattle Center of Innovation for Veteran-Centered and Value-Driven Care and the Associate Director of the Seattle Center of Excellence in Substance Abuse Treatment and Education (CESATE), one of two national VA centers devoted to improving the quality of care and clinical outcomes of veterans with substance use conditions. He also is an Associate Professor in the Department of Psychiatry and Behavioral Sciences at the University of Washington and a licensed clinical psychologist in Washington State. His primary research interests include evaluating and improving behavioral health and substance use outcomes of Veterans with alcohol and/or drug misuse conditions. He received his PhD in Clinical Psychology from Brigham Young University.
Additional Resources:
- Download slides (pdf)
The CTN webinar “Measurement-Based Care: Isn’t It About Time We Used It?,” was presented by Dr. A. John Rush, MD, on July 28, 2017 at 1pm ET.
As we continue to provide quality, evidence-based treatment methodologies in healthcare and research, it is important to develop and evaluate the tools used as well as procedures followed in standard care to assess and monitor patient progress. This webinar explored opportunities to improve the development and utilization of measurements to affect patient outcomes. During this one-hour presentation, Dr. Rush defined Measurement-Based Care (MBC), evaluated benefits to using MBC, and discussed application and outcomes focusing on depression as an example to illustrate the use and value of MBC.
A. John Rush, MD is Professor Emeritus, National University of Singapore (Duke-NUS) and holds Adjunct Professorships at Duke University and Texas Tech University medical schools. He has authored over 800 professional publications on the diagnosis, treatment, biology, psychology, and systematic clinical care of persons with mood disorders. As a clinical researcher and practitioner, he is dedicated to advancing science to serve patients who are afflicted with these and related conditions and their families. He was PI of the Texas Medication Algorithm and the STAR*D projects – both of which employed measurement based care. He was recognized as one of the “World’s Most Influential Scientific Minds” by Thomson Reuters in 2014. With prior clinical and research experience with SUD patients, Dr. Rush is a consultant to the CTN.
Additional Resources:
- Download slides (pdf)
In preparation for the conduct of a clinical trial, investigators must plan for the management of medications used as an intervention or a supportive drug. In setting up for a study, there are various aspects to consider for implementation, tracking, and quality assurance. This one-hour seminar discussed drug management planning and implementation considerations for trials in the CTN.
Additional Resources:
- Download slides (pdf)
- Download handout (pdf)
The NIDA Data Share website was created to make CTN data available to the scientific community and the public at large. These data can be used for secondary analyses and thus serve to increase the contribution of the original studies conducted and extend findings into new areas and knowledge for the benefit of public health. This one-hour webinar, presented by Abigail Matthews, PhD, of the Emmes Corporation, and Dikla Shmueli-Blumberg, PhD, of the CTN Clinical Coordinating Center, focused on an overview of the website, provided highlights of its structure and contents, and detailed the technical procedures involved in utilizing the data for secondary analyses.
Additional Resources:
- Download slides (pdf)
- Download handout (pdf)