VCU to lead clinical trial assessing preventive treatment for patients recovering from opioid overdose

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The Wright Center for Clinical and Translational Research will provide funding and research infrastructure for this opioid clinical trial. Dr. Moeller, the Center’s director, will serve as principal investigator on the trial!

Virginia Commonwealth University today announced that it is leading a clinical trial to test SUBLOCADE™ (buprenorphine extended-release) injection for subcutaneous use (CIII), a once-monthly injectable formulation of buprenorphine for the treatment of moderate-to-severe opioid use disorder.

The VCU-led clinical trial will test innovative methods to prevent repeat opioid overdose by recruiting patients into treatment immediately after they recover from an overdose. During the 18-month clinical trial, VCU researchers will study SUBLOCADE-assisted intervention in adults diagnosed with opioid use disorder who have been successfully treated for an opioid overdose in the emergency department and immediately brought to outpatient treatment.

The research will involve collaboration with Virginia Tech Carilion Research Institute and Inova Fairfax Hospital.

F. Gerard Moeller, M.D.
F. Gerard Moeller, M.D.

“The main goal of the research is to develop a new treatment paradigm for patients after an overdose,” said F. Gerard Moeller, M.D., professor of psychiatry, pharmacology and toxicology, and neurology at VCU School of Medicine and director of the VCU Institute for Drug and Alcohol Studies. Moeller will serve as principal investigator on the trial. He will be joined by Robert Lipsky, Ph.D., director of translational research in the Department of Neurosciences at Inova Fairfax Hospital, and Warren Bickel, Ph.D., professor of psychiatry and director of the Addiction Recovery Research Center at Virginia Tech Carilion Research Institute.

The clinical trial is jointly funded by the Virginia Biosciences Health Research Corporation, Virginia Commonwealth University and Indivior Inc., which is headquartered in Richmond. Indivior has been developing medications to treat opioid use disorder for more than 20 years and is providing SUBLOCADE for use in the trial. Funding for the clinical trial is housed at the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, where Moeller serves as director. The Wright Center will also provide research infrastructure for the clinical trial.

“We look forward to collaborating with VCU, Inova Fairfax Hospital and Virginia Tech Carilion Research Institute to study the effects of SUBLOCADE in the emergency environment together with behavioral therapy in outpatient treatment to possibly prevent repeat opioid overdoses and potentially change the standard of care for those who are recovering from opioid overdose,” said Christian Heidbreder, Ph.D., chief scientific officer at Indivior.

Standard treatment for an overdose until this point has started with first responders administering an opioid overdose reversal drug to a patient following an overdose. The reversal drug saves the patient’s life, but it also puts the patient into withdrawal as they are transported to a hospital, where they are typically monitored for a few hours before being sent home with a referral for outpatient addiction treatment.

“Unfortunately, the relapse rate is high,” Moeller said, adding that patients typically are not receptive to a referral for addiction treatment when they are in withdrawal.

The proposed new paradigm would allow treatment to begin in the emergency room, with an active referral and immediate transportation to the outpatient clinic. At the outpatient clinic, patients would receive SUBLOCADE and meet with a behavioral therapist.

“We know that treatment programs work when they combine medication with continuing addiction health care and support,” said Bickel, whose research since 1983 has helped lead to opioid replacement therapies that are currently in use.

It would be a new treatment paradigm for patients after an overdose.

Patients will be recruited for the trial from VCU Medical Center’s Emergency Department and will receive follow-up care at the VCU Health MOTIVATE Clinic. Virginia Tech is collaborating on development of behavioral biomarkers of addiction related to impaired decision-making. Inova is contributing research on personalized medicine and pharmacogenomics of opioid overdose.

“This research could have a major impact on a public health emergency,” Moeller said. “It would be a new treatment paradigm for patients after an overdose, with the goal of reduction of repeat overdoses and deaths.”

About VCU and VCU Health

Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located in downtown Richmond, VCU enrolls more than 31,000 students in 220 degree and certificate programs in the arts, sciences and humanities. Seventy-nine of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. The VCU Health brand represents the health sciences schools of VCU, the VCU Massey Cancer Center and the VCU Health System, which comprises VCU Medical Center (the only academic medical center and Level I trauma center in the region), Community Memorial Hospital, Children’s Hospital of Richmond at VCU, MCV Physicians and Virginia Premier Health Plan. For more, please visit www.vcu.edu and vcuhealth.org.

CCTR Hosts Final Fall Brown Bag Seminar Featuring OnCore Discussion

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The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research hosted its fifth and final seminar as part of an ongoing Fall Brown Bag series where representatives from the VCU Wright CCTR raised awareness of the various tools and services offered by the Center. 

Robert “Bobby” Moulden, manager of Clinical Trials Management System for the VCU Wright CCTR, led this presentation with a particular focus on Online Collaborative Research Environment (OnCore), which is a Clinical Trials Management System (CTMS) designed specifically for large academic medical centers with vibrant, expanding clinical research programs. The event received a large turnout with representatives from the VCU Department of Pathology, VCU Massey Cancer Center, VCU Department of Neurosurgery, and the VCU Department of Internal Medicine, among others in attendance. 

OnCore is a web-accessible, centralized database with role-based security. It provides a platform to track clinical research studies and participants, and includes features such as  audit/monitoring capabilities, electronic case report forms (eCRFs), and custom reporting. Additionally, patient research participation is now shared from OnCore to Cerner through an integration.

Moulden and his team reviewed OnCore’s audit console, which supports a standard institutional audit process and incorporates input provided by the VCU Office of Research and Innovation’s Clinical Research Compliance Program, the Institutional Review Board, and VCU Massey Cancer Center.

“OnCore helps coordinators work together on the most up to date forms and information,” Moulden said. “It eliminates the need for teams to email files back and forth and provides a secure platform for materials containing patient health information.”

To learn more about OnCore, visit go.vcu.edu/oncore or go.vcu.edu/wiki. Email OnCore@vcu.edu with questions.

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First image up top: Robert “Bobby” Moulden, manager of Clinical Trials Management System for the VCU Wright CCTR

Antonio Abbate and Jennifer Economy Lead Presentations on Scientific Review Committee

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Last week, the VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research (Wright CCTR) sponsored a series of Brown Bag Lunch seminars on the new VCU Scientific Review Committee (SRC) which is set to begin reviewing research projects in September 2016.

The presentations were led by Jennifer Economy, M.S.H.A., SRC executive director, and Antonio Abbate, M.D., Ph.D., medical director of the Wright CCTR’s Clinical Research Services, and associate chair of the SRC.

The mission of the SRC is to ensure that all research projects involving humans at VCU meet acceptable standards of scientific rigor and feasibility without obstructing institutional efficiency and timeliness. 

“The SRC leaders and members understand the challenges of getting ideas to become studies, and studies to yield results,” said Economy. “Every researcher we asked to join this team was excited about the opportunity. It’s truly a passionate group of people who have assembled for the cause.”

Economy went on to explain that VCU is on a path to becoming a premier, urban research institute. The existence of an SRC at VCU puts the University in line with other leading academic research institutions who have already adopted the SRC program.

The publication of a special reported titled, “CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes,” in Clinical and Translational Science (CTS), the official journal of the American Society for Clinical Pharmacology and Therapeutics, motivated VCU to re-start the SRC process. In the past, the former General and Clinical Research Center (GCRS) led a GCRC Advisory Committee (GAC) for many years. When VCU established the VCU Wright CCTR in 2007 and later received a $20 million Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH), the GAC was dissolved with the idea being that it would reconfigured in the future to meet the demands of translational research at VCU. 

“The SRC group believes in teaming up to do great research at VCU,” said Abbate. “We want this process to be a help, not a burden to researchers, and it is important to us that the experience be transparent for all those involved.”

To learn more about the SRC, visit www.cctr.vcu.edu/src or contact Jennifer Economy at jennifer.economy@vcuhealth.com.
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Second image: Jennifer Economy, M.S.H.A., SRC executive director

Fifth image: Antonio Abbate, M.D., Ph.D., medical director of the Wright CCTR’s Clinical Research Services, and associate chair of the SRC

CCTR Hosts Final BIC Brown Bag Seminar Focused on Cohort Discovery and Clinical Data Reporting

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The C. Kenneth and Dianne Wright Center for Clinical and Translational Research (CCTR) hosted the final seminar in the BIC Brown Bag Lunch series which featured the various resources offered by the CCTR’s Biomedical Informatics Core (BIC).

On Thursday, May 12, Shannon Bruffy, IT specialist for BIC, and Jun He, research informatics application analyst for BIC, led a presentation on cohort discovery and clinical data reporting.

i2b2Bruffy focused her portion of the presentation on Cohort Discovery (i2b2), a tool that was developed at Harvard Partners Healthcare through a CTSA grant. i2b2 allows users to search a de-identified database, without IRB approval, to determine the existence of a set of patients meeting specified criteria. She also reviewed best practices for effective query building, which includes searching by time, multiple key words, and proper codes.

Jun He discussed the limitations and abilities of data extraction. Stressing the importance of good practice when submitting requests for data, He asked that requests be made after IRB approval has been obtained, with the conditions for requests provided, and with acronym explanations.

To submit a BIC request and learn if you’re eligible for assistance, visit go.vcu.edu/bicrequest.

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First image up top: Shannon Bruffy, IT specialist for CCTR’s Biomedical Informatics Core

Third image from top: Jun He, research informatics application analyst for CCTR’s Biomedical Informatics Core

Dr. Jamie Sturgill Leads Discovery Dialogue on New Pathways to Controlling Asthma

11x16 Brandbar HeaderJamie Sturgill, Ph.D., assistant professor and director of Biobehavioral Laboratory Services for the VCU School of Nursing, led a Discovery Dialogues presentation in the Main Hospital’s Learning Center on Monday, April 11 to a mixed audience of VCU researchers, health care professionals and staff.

In her presentation titled, “A Breath of Fresh Air – Discovering New Pathways to Control Asthma,” Sturgill reviewed the immune response in allergic asthma, such as airway hyperreactivity, eosinophil infiltration, and mucus hypersecretion, in addition to the current treatment options. 

“At this time there is no way to prevent asthma, only control or treat it,” Sturgill said. “This is largely due to the fact that asthma is a large umbrella term and it’s difficult to characterize every type of allergy people have.”

The residents of Richmond, Virginia experience, first hand, the adverse side effects of spring allergies. Last year, the Asthma and Allergy Foundation of America’s yearly Asthma Capitals report listed Richmond as the second most challenging city to live in with asthma.

Sturgill explains this as Richmond being a ‘perfect storm’ for asthma triggers and cited diesel exhaust from Interstate 64 and Interstate 95, mold in the James River, a large population of dust mites due to the city’s hot and humid temperature, and an urban environment as just a few of the contributing factors.

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First image up top: Jamie Sturgill, Ph.D., assistant professor and director of Biobehavioral Laboratory Services for the VCU School of Nursing