The nation has been grappling with the opioid epidemic for years-;and the city of Philadelphia has been hit hard by the crisis. While data is showing slight declines in overdose deaths, the opioid crisis remains a public health emergency. Efforts to stem the epidemic have included prescribing fewer painkillers, providing free naloxone trainings across the city, offering recovery programs in emergency departments, and launching dedicated research efforts to examine the cause and impact.
The National Institutes of Health (NIH) announced awards from the Helping to End Addiction Long-term Initiative (NIH HEAL Initiative), which was launched in April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. Though this initiative, Penn Medicine has been awarded five grants totaling more than $22 million to apply scientific solutions to reverse the national opioid crisis.
New strategies to prevent and treat opioid addiction
A team lead by David Mandell, ScD, a professor of Psychiatry and director of the Center for Mental Health, Kyle Kampman, MD, a professor of Psychiatry and director of the Charles O'Brien Center for the Treatment of Addictions, and Hillary R. Bogner, MD, MSCE, an associate professor of Family Medicine and Community Health, is receiving a $11.2 million grant from the initiative.
- Their team will study the treatment of opioid use disorder (OUD) and psychiatric disorders in the primary care setting with a collaborative care model. The collaborative care model places licensed clinical social workers specially trained in mental health care in primary care offices. These experts will work with 39 primary care practices in Philadelphia, their primary care physicians, and psychiatrists to proactively identify, assess, and direct patients to treatment options as needed during their appointments.
- Other Penn investigators include Dave Oslin, Jim McKay, Kevin Lynch, Courtney Benjamin-Wolk, Rebecca Stewart, and Cecilia Livesey.
Clinical Research in Pain Management
Laura M. Dember, MD, a professor of Medicine in Renal-Electrolyte and Hypertension and Epidemiology, was awarded a $5.5 million grant from the NIH HEAL Initiative.
- Penn will serve as the Scientific and Research Data Center for the Hemodialysis Opioid Prescription Effort (HOPE) consortium. The center will provide scientific and operational leadership for the design, implementation, and analysis of a randomized clinical trial of behavioral and pharmacologic interventions to reduce pain and opioid use among people with kidney failure receiving maintenance hemodialysis. The trial will be conducted at eight clinical centers that are separately funded by the HEAL initiative.
- Richard Landis, PhD, a professor of Biostatistics, John Farrar, MD, PhD, an associate professor of Epidemiology, and Kampman are co-principal investigators. Additional Penn investigators included Martin Cheatle,Jesse Hsu, Danielle Mowery, and Steven Joffe. Nwamaka Eneanya, MD, MPH, will serve as a co-investigator for the University of Pittsburgh/University of Pennsylvania HOPE clinical center.
Farrar was also awarded a $931,000 grant from the NIH HEAL Initiative. The Hospital of the University of Pennsylvania and six additional Penn Medicine centers will serve as Specialized Clinical Centers -; or "hubs"-; for the NIH's Early Phase Pain Investigation Clinical Network (EPIPIC-Net).
- The Specialized Clinical Centers will provide infrastructure to implement high-quality, comprehensive studies of patients with well-defined pain conditions, as well as the design and performance of two clinical trials to test promising new treatments for pain. The Penn Medicine site will assist the EPPIC-Net to make clinical, neuroimaging, biomarker, and preclinical data, as well as biosamples, available through public access data and biospecimen repositories.
- Michael Ashburn, MD, MPH, director of Pain Medicine and Palliative Care, will serve as co-principal investigator. Annamarie Horan, PhD, is an additional Penn investigator.
Novel medication options for opioid use disorder and overdose
Kampman and George E. Woody, MD, a professor in the department of Psychiatry, have been awarded $4 million from the NIH to study a path towards improving the success of opioid detoxification, focusing on a transition to extended-release injectable naltrexone (XR-NTX), a medication that reduces opioid relapse and overdose risk.
- Transitioning to XR-NTX requires motivation and detoxification, which are major hurdles for those with an OUD. Detoxification with lofexidine-;a medication approved by the Food and Drug Administration for opioid detoxification about one year ago-;does not have much effect on the achiness and other symptoms of withdrawal that lead some patients to drop out of treatment. The study will test whether pregabalin-;a medication shown in studies to suppress many of those withdrawal-related symptoms-;can be safely combined with lofexidine to improve the success of detoxification and transition to XR-NTX treatment, as compared to lofexidine alone.
- Additional Penn investigators include Daniel Langleben and Kevin Lynch.
Enhanced outcomes for infants and Children Exposed to Opioids
A team led by Dylan Tisdall, PhD, a research assistant professor of Radiology, and Allyson Mackey, PhD, an assistant professor of Psychology, were awarded a $550,000 grant from the initiative.
- The researchers will conduct a feasibility study to address the knowledge gap in understanding how opioid exposure impacts early brain development. While neuroimaging studies in young children offer an opportunity to quantify these developmental processes, existing imaging methods are not ideal for this group of patients, since young children exposed to opioids are prone to in-scanner motion. The Penn team plans to develop novel neuroimaging methods optimized for young children. They will evaluate these methods in a sample of 100 children, ages three to five, recruited from the community in Philadelphia that has been hardest hit by the opioid crisis. They will test whether the new technologies improve the quality of the raw imaging data and reduce motion biases.
- Kristin Linn is an additional Penn investigator.
It's clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids. This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis."
Francis S. Collins, MD, PhD, NIH director who launched the initiative in early 2018