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.

Changing policies impact NIH-funded studies!

 

The NIH announces numerous policy changes to improve the stewardship of clinical trials.

Please read the full announcement here:


Message to NIH grant applicants/awardees, contractors, researchers and research administrators:

If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

  • select the right NIH funding opportunity announcement
  • write the research strategy and human subjects sections of your application
  • comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.

For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.

Second, take a moment to answer these four questions about your current or proposed research:

1) Does the study involve human participants?

2) Are the participants prospectively assigned to an intervention?

3) Is the study designed to evaluate the effect of the intervention on the participants?

4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.

Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure?  Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

  • the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
  • Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
  • updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
  • new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
  • use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
  • expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:

  • respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
  • facilitates design of clinical trials while reducing unnecessary duplication
  • promotes broad, timely, and responsible dissemination of research information and results
  • fosters responsible stewardship of the public’s investment in biomedical research

We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know.  Please review this information carefully.  Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.

We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on my blog.

The success of clinical trials relies on the public trust in scientific rigor and ethical oversight.  We all play a critical role in this process.  We are most grateful to you for your help and support.

Best,

Michael S. Lauer, MD

Deputy Director for Extramural Research, NIH

One Center Drive, Building 1, Room 144

Bethesda, MD 20892

 

NIH and FDA release clinical trials protocol template

 

NIH and FDA develop and release a clinical trials protocol template. 

NIH and FDA collaborated with the research community to develop a common Phase 2 and Phase 3 IND/IDE clinical trial protocol template. The goal is to support investigators and speed up FDA review of NIH clinical trials. The document is consistent with International Council for Harmonisation E6 (R2) Good Clinical Practice Guidance.

At the same time, NIH released an electronic protocol writing tool that allows investigators to work together in a common platform to develop their protocol. NIH anticipates future releases of the e-Protocol Writing Tool will include templates for Phase 1 and behavioral studies.

Please note that the use of these tools is optional. Individual Schools/Centers/Departments may already have protocol template requirements in place. 

NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials

Notice Number: NOT-OD-17-064

Key Dates

Release Date: May 2, 2017

Related Announcements

NOT-OD-16-043

Issued by

National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) developed a clinical trial protocol template with instructional and example text for NIH-funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications.   In March 2016 a draft template was released for public comment generating nearly 200 comments from 60 respondents.  All comments were carefully considered and many were incorporated into the final template.  The agencies’ goal is to encourage and make it easier for investigators to prepare clinical trial protocols that are organized consistently and that contain all of the information necessary for the review of the protocol.  The template follows the International Conference on Harmonisation (ICH) E6 (R2) Good Clinical Practice and is available as a Word document

The NIH also released a secure web-based e-Protocol Writing Tool that allows investigators to generate a new protocol using the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template. The e-Protocol Writing Tool fosters protocol writing collaboration by allowing multiple writers and reviewers to participate in the protocol development process. The e-Protocol Writing Tool allows the author to assign writers and collaborators and the tool assists the author with tracking progress and document version control.

The NIH expects to expand the development of the e-Protocol Writing Tool by adding instructional text and sample text for other types of studies, such as a behavioral and phase 1 trials. Future releases of this e-Protocol Writing Tool will have improvements and enhanced tool functionality.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy

Telephone: 301-496-9838

Email: SciencePolicy@od.nih.gov

 

 

International Clinical Trials Day!

The Wright Center for Clinical and Translational Research sponsored the International Clinical Trials Day event on May 19th at the VCU Gateway Building. Visitors, patients, and staff learned about the history of clinical trials, how to navigate StudyFinder-the central point for enrolling in clinical trials, and discovered how research is changing patients lives!  “I have seen so many patients being positively impacted by Clinical trials and everyone in VCU Health systems works hard to make sure that is always the reality.  Happy International Clinical trials day.” Sofanit Almaw Dessie Our staff and clinical trial participants are true heroes-making advances every day in research to improve patient outcomes! To make a difference, get involved in research, or find out about exciting clinical trials go to: https://studyfinder.cctr.vcu.edu/

Mary Madu and Kimberly Bradley Lead Brown Bag Presentation on Clinical Trial Recruitment

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The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research (VCU Wright CCTR) hosted the second in its five-part Fall Brown Bag Lunch seminar series. Attendees were encouraged to bring their lunch and learn about best practices for clinical trial recruitment in a presentation led by Kimberly Bradley, EMT, CCRP, manager of the coordinator pool for the CCTR’s Clinical Research Services (CRS), and Mary Madu, CCRC, advanced research coordinator for the CRS.

“People need to be invested in their own care before others can invest in them,” Madu said. “I try to be a support and source of education for folks so they can make informed decisions about their health and participation. Clinical trials have the opportunity to be a fun and really positive experience for all parties involved once participants are invested in themselves and they see that I am invested in them and the work that I do.” 

In addition to sharing their own best practices in clinical trial recruitment, Madu and Bradley discussed the various free resources available at VCU, including StudyFinder, ResearchMatch, and the VCU Clinical Trials Facebook page

“Exposure is an opportunity to educate,” Bradley said. “The more potential participants hear and learn about clinical trials, the more they’ll feel comfortable with the idea of participating. I always go back to the importance of education, whether that’s at the level of a participant, coordinator, or study team… Everyone can benefit from education.”    

The discussion of consent as a form of empowerment for participants was also discussed at length. For those suffering from a serious disease or illness, oftentimes they may feel as if they don’t have a choice in the care they receive or decisions that are made. It is the responsibility of the study team to stress that participating in a clinical trial is a choice that participants make for themselves.

“I consider my study participants to be invited guests and I treat them as such,” Madu said. “I want them to know that there is tremendous value in participating in a clinical trial, but that they have the power to remove themselves from it at any time. It’s important to me that they have a positive experience because I want them to know that I believe their time is valuable and they are valuable.”

To learn more about the VCU Wright CCTR’s Clinical Research Services, visit www.cctr.vcu.edu/clinicalresearch.

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Mary Madu, CCRC, advanced research coordinator for the CRS
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Kimberly Bradley, EMT, CCRP, manager of the coordinator pool for the CRS

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VCU Involved in Adolescent Brain Cognitive Development (ABCD) Study – 10,000 Children to Participate

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The VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research (Wright CCTR) and the VCU Institute for Drug and Alcohol Studies are proud to announce that Virginia Commonwealth University is slated to begin recruitment within the coming weeks for the Adolescent Brain Cognitive Development (ABCD) study, the largest long-term study of brain development and child health in the United States.

logo_abcd_1000x529The National Institutes of Health (NIH) will follow the biological and behavioral development of more than 10,000 children beginning at ages 9-10 through adolescence into early adulthood. Recruitment will be done over a two-year period through partnerships with public and private schools near research sites across the country as well as through twin registries.

“The ABCD project is the largest long-term study of brain development and cognition in the United States,” said F. Gerard Moeller, M.D., director of the VCU Wright CCTR and the VCU Institute for Drug and Alcohol Studies. “This is an important collaboration across institutes and centers within VCU and across the United States.

Virginia Commonwealth University is one of four sites out of the 19 total ABCD Consortium sites that will recruit pairs of twins. With the support of the VCU Office of Research and Innovation, the VCU Wright CCTR’s Mid-Atlantic Twin Registry will aim to recruit 200 pairs of twins from Virginia and other surrounding states.

“Incorporating twins into the ABCD study provides researchers with a unique ability to study ‘what-if’ questions,” said James M. Bjork, Ph.D., associate professor in the VCU Institute for Drug and Alcohol Studies, the VCU Department of Psychiatry, and the VCU Department of Pharmacology and Toxicology. “By testing twins that may differ on various experiences, researchers can more confidently link experiences in a child’s life to how his or her brain developed. This enables us to approximate that ‘what if’ scenario, and add additional scientific value to the ABCD Consortium.”

The ABCD longitudinal study will also utilize advances in imaging technology, which were recently installed in the Wright CCTR’s Collaborative Advanced Research Imaging (CARI) MRI scanner.  The CARI scanner employs cutting-edge “multiband” technology to stimulate multiple portions of the brain simultaneously and read out all of the data from those slices. This technology dramatically improves the sensitivity of MRI testing and enables VCU researchers to receive finer spatial resolution images or take more images over time than previously able.

Visit www.abcdstudy.org to learn more about the study.

Official NIH press release below [Download here]:

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Clinical Trials Awareness Week May 2-6, 2016

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AFPA_CTAW_Logo_FinalWhether you’ve taken a medication today to manage a chronic disease or simply to keep a headache at bay, you know that medical innovations have the power to change lives.

But these breakthroughs don’t just happen. Developing new medicines is a lengthy and complex process, relying heavily on volunteer participation to evaluate potential therapies for safety and effectiveness in clinical studies. Without the patients who volunteer to participate in clinical trials, the development of new medicines would not be possible.

During Clinical Trials Awareness Week, May 2 – 6, 2016 we recognize the individuals who have made new, innovative treatments a reality for patients worldwide – clinical trial researchers and participants. By shining a spotlight on these unsung heroes, we can raise awareness about the importance of participating in a clinical trial.

Clinical trials may benefit participants by providing them the opportunity potentially to receive an investigational drug that is not available to people outside the trial. In addition, they may receive treatment from a clinical research team that provides careful oversight of their medical condition. Also, many participants report great satisfaction playing a key role in advancing medical science and helping scientists find new treatments that will help more people live longer, healthier lives. The Center for Information and Study on Clinical Research Participation (CISCRP) reports that 95 percent of clinical trial participants would consider joining a future clinical trial.

Everyone should have access to helpful information about clinical trials and the opportunity to determine if participating in a clinical trial is the right choice for them. Visit our VCU Clinical Trials Facebook page and join the CCTR in spreading the word about the importance of clinical trial participation.