NSU Researchers Combat Opioid Abuse from a Different Angle
Combating a deadly epidemic of opioids, Hossein Omidian, Ph.D., and his research team at Nova Southeastern University are developing tamper-resistant tablets and abuse-deterrent technologies to prevent users from snorting or injecting prescription pain medications.
Learn how NSU's research team is combating opioid abuse
Learn more about the epidemic of prescription pain medications
Nova Southeastern University’s scientists are engaged in exciting interdisciplinary research projects to make discoveries and produce new knowledge in healthcare, biotechnology, life sciences, environment and social sciences. NSU faculty are using more than $107 million in externally provided funding to work on projects that advance the university’s mission of research, academic excellence, and public service. They are working on hundreds of basic, applied and clinical research projects to improve patient care, make new drug discoveries, reduce mental health disorders, and examine the forces that impact our oceans.
Chronic fatigue syndrome/myalgic encepahalomyelitis (CFS/ME) is a debilitating immune disorder that affects more than one million Americans. A majority of CFS/ME sufferers are women, who remain mostly untreated. The disease damages the patient’s immune system and causes symptoms such as extreme fatigue unabated by sleep, faintness, widespread muscle and joint pain. NSU’s Institute for Neuro-Immune Medicine ---- led by Nancy Klimas, M.D., professor in NSU’s Dr. Kiran C. Patel College of Osteopathic Medicine, one of the world’s leading CFS/ME and Gulf War Illness (GWI) researchers --- is studying these and other neuro-inflammatory disorders. The Institute uses the integration of research, training and clinical care to advance the needs of patients suffering from CFS/ME and GWI. By bringing together some of the best scientific minds in the world, the facility acts as both a think tank and a working institute for research, training new clinicians, and providing diagnostic and therapeutic clinical care.
By creating the new epinephrine tablet (Epi tablet), Mutasem Rawas-Qalaji, Ph.D., fills a need in the health-consumer market–a development that may drastically improve the lives of children and adults who require epinephrine to combat severe allergic reactions.
“Anaphylaxis is a severe and potentially fatal allergic reaction requiring immediate treatment,” said Rawas-Qalaji, pharmaceutical researcher and associate professor at Nova Southeastern University (NSU) College of Pharmacy, who developed the Epi tablet with the help of his Ph.D. and Pharm.D. students.
“Epinephrine tablets are sublingual tablets that disintegrate very quickly under the patient’s tongue and release epinephrine to be absorbed directly into the blood stream. It can reach the same concentration achieved by an epinephrine injection,” he said.
Foods such as peanuts, fish, shellfish, latex, and some medications are causes of anaphylactic shock. Today, the only available self-medication is an epinephrine auto injector–whose consumers have seen a 500 percent price increase in 10 years.
“Some patients don’t like to inject themselves and sometimes there’s an anxiety associated with administering the epinephrine injection,” Rawas-Qalaji said.
Epinephrine tablets offer a convenient, patient-friendly, and less invasive method to self-administer epinephrine and a potential reduction in patient anxiety, errors, and cost. Epinephrine tablets are less bulky, easier to handle, and have a longer shelf life than epinephrine injections.
“We are working to advance the product development and finish clinical trials as soon as it is feasible. If we are able to show the same safe efficacy level as in the preclinical studies, I think we will be very close to putting this product on the market by 2020.”
There are more than 200,000 new cases of breast cancer annually in the U.S. About 1 in 8 (12%) of women in the U.S. will develop invasive breast cancer during their lifetime. A research team Jean Latimer, Ph.D., associate professor of pharmaceutical sciences, NSU’s College of Pharmacy, and Stephen Grant, Ph.D., associate professor of public health, NSU’s College of Osteopathic Medicine, has developed a unique method of growing breast cancer cells from tumors at early stages of the disease, enabling further studies into the causes of tumors and indicating when and what kind of chemotherapy should be used.
Most individuals whose alcohol problems are not severe, particularly college students and young adults, do not seek treatment. NSU's College of Psychology researchers Linda Sobell, Ph.D., and Mark Sobell, Ph.D., supported by several federally-funded research grants have successfully recruited such individuals to participate in alternative interventions (vs. coming in to a treatment program). Several of their studies have shown that many people with alcohol problems can successfully change their drinking with minimal help. Recently, they developed an iPhone app called iSelfChange™ that has helped younger drinkers successfully reduce their drinking. The importance of the iSelfChange™ app is that it is available 24/7, confidential, novel, free, and provides a non-stigmatizing way of helping people change their alcohol use without entering treatment. Such interventions could help many people, while minimizing costs to the national health care system.
Ana M. Castejón, Ph.D., associate professor at NSU’s College of Pharmacy, is principal investigator (PI) of an ongoing multidisciplinary research study about the role of glutathione in autism. This multidisciplinary study involves different NSU academic centers and is the first investigator-initiated clinical trial at NSU. As the PI of this project, Castejon, is in charge of designing and implementing a study investigating a nutritional supplement and its role in behavioral changes in children with autism. In addition, she was responsible for creating a protocol and method to quantify glutathione in children with autism spectrum disorders.
Comparing two Interventions for Teaching Math to Preschool Children with ASD.
The study, funded by NSU’s PFRGD compares two interventions for teaching math to preschool-age children with ASD. The first is considered business as usual, which teaches the Strategies for Teaching Based on Autism Research (STAR) curriculum and discrete trial teaching; the second is the Math is Not Difficult (Project MIND) activity-embedded, naturalistic intervention.
Comparing Teacher-Led and Computer Instruction in Preschoolers with Autism
The study, funded by NSU’s PFRDG, compares the effectiveness of two interventions that are used with students with autism spectrum disorder at the preschool level. A teacher-led intervention, strategies for teaching based on autism research (STAR) with a curriculum-based assessment that is currently in use at the Baudhuin Preschool. It is based on the science of applied behavior analysis and uses discrete trial teaching (DT) to teach receptive language and pre-academic concepts. TeachTown, an intervention that is computer-assisted.
Millions of people take angiotensin receptor blockers (ARBs) to help treat heart failure. But it turns out not all ARBs are created equally, according to Anastasios Lymperopoulos, Ph.D., F.A.H.A., assistant professor of pharmacology at NSU’s College of Pharmacy. Lymperopoulos, along with his research team, conducted a study on biological models over a seven-day period that found Valsartan (Diovan) and Candesartan (Atacand) were more effective than Irbesartan (Aprovel, Karvea and Avapro) at preventing the increased production of the hormone aldosterone, which, if untreated, can lead to heart failure. These findings can help cardiologists and other clinicians tremendously when they are deciding which ARB drug to choose for the treatment of heart failure patients. This work was partially supported by American Heart Association Grant No. 09SDG2010138.
For the ongoing threats of pandemics, the NSU Institute for Disaster and Emergency Preparedness in the College of Osteopathic Medicine conducts assessments to measure the preparedness of vulnerable population groups including an aging population, those with intellectual and developmental disabilities, and tourists. The institute provides training throughout the United States on disaster and emergency preparedness and examines the preparedness of all populations trained. The Institute has established ongoing and updated programs on pandemics to increase the knowledge of both health care professionals and the lay public. In response to the Ebola outbreak of 2014 in the U.S., the Institute initiated a project to examine the knowledge of Ebola among various health professionals and students.
Much of biology pivots on the action of genes, microbes and evolution. Microbes live on almost every available habitat of the planet and provide mostly beneficial services and products, such as oxygen to breathe and potential new medicines. Genes and the DNA that all organisms have, represent the thread that connects all life forms including microbes and simple marine organisms. Biotechnology has now provided faster and less expensive ways to generate genetic sequence data that impacts multiple biological disciplines such as medicine, molecular biology and ecology. Evolution hinges on the variation in DNA sequences.
Jose V. Lopez, Ph.D. associate professor at NSU’s Oceanographic Center, researches marine invertebrate-microbial symbiosis, genomics and metagenomics, gene expression of oil-exposed organisms, marine microbiology and the organization of organismal relationships called systematics/phylogenetics. He is part of the newly initiated Global Invertebrate Genomics Alliance or GIGA, that will apply genome sequencing of non-model invertebrate species, and Lopez is also involved with other sponge biologists to help characterize microbial diversity via high throughput DNA sequencing in the global Earth Microbiome Project (earthmicrobiome.org) and the DEEPEND consortium (Deep Pelagic Nekton Dynamics of the Gulf of Mexico –http://www.deependconsortium.org).
NSU scientist Appu Rathinavelu, Ph.D., executive director of NSU’s Rumbaugh Goodwin Institute for Cancer Research (RGICR) and associate dean at the College of Pharmacy, is finding new therapeutics to treat deadly cancers. After 10 years of work and collaboration with the scientists at the Lombardi Cancer Center of Georgetown University, Rathinavelu discovered and patented two new drugs. These drugs are designed to destroy blood vessels that supply oxygen and nutrients through blood circulation to cancer tissues. This will eventually shrink and destroy the cancer tissues. Once the pre-clinical trials are completed these drugs could enter into clinical trials for breast, lung, prostate, ovarian and colorectal cancers.
Viral infections and cancers are major health concerns with limited available and effective therapies. Oncolytic (cancer-killing) viral therapy is in its infancy because systemic viral infections are difficult to control. Paula Faria Waziry, Ph.D., has uncovered a widely-used class of drugs capable of modulating oncolytic virus replication and antiviral nucleoporins (family of proteins) expression. She has filed a patent that repurposes the use of such drugs as: (a) chemotherapeutic suppressant to eliminate of highly metastatic cancers and (b) broad-spectrum antiviral modulator.
Umadevi Kandalam, Ph.D., assistant professor, Department of Pediatric Dentistry, College of Dental Medicine, is leading a research team that focuses on stem cell based tissue regeneration, with a special attention on craniofacial bone repair. Her laboratory employs neural crest and mesenchyme derived oro-facial stem cells. The current focus of her research group is to develop an injectable stem cell-growth factor-scaffold system for regeneration of bone in cleft and alveolar region. This research would help to avoid multiple surgeries and benefit many children.
The synthetic ceramic zirconia is an important material in dental and orthopedic restorative treatments because of its excellent biocompatibility and durability. Jeffrey Y. Thompson, Ph.D., director of the Biosciences Research Center at NSU’s College of Dental Medicine, is developing novel surface treatments to enhance the adhesion, efficacy and reliability of zirconia in a variety of dental applications.
A research team at NSU’s College of Pharmacy led by professors Jean Latimer, Ph.D. and Stephen Grant, Ph.D., discovered that, contrary to prior belief, tissues of different mammalian organs have very different abilities to repair damage to their DNA. Their new findings indicate that the heart has the greatest capacity to repair its DNA, followed by the intestines, kidneys, spleen, testes, and lungs. The brain, however, exhibited no ability to repair damage to its DNA. DNA repair is a complicated process that requires a high level of metabolic investment by the cell. Brain cells may focus their energies on other more essential activities, and are not commonly exposed to UVC light, perhaps explaining their undetectable level of repair. These findings could help explain causes of dementia and memory loss. This research was supported by the National Cancer Institute of the National Institutes of Health under award number R29CA71894.
The Marine LarvaI Ecology Lab at NSU’s Oceanographic Center is studying how larval survival and settlement competency dynamics determine dispersal, connectivity and resilience of corals. Joana Figueiredo, Ph.D., assistant professor, and her students are interested in understanding how corals will cope with climate change, and if these impacts can be mitigated through the reduction of local stressors, such as sedimentation. Figueiredo’s team is also assessing the extent and rate at which marine invertebrates may adapt and/or acclimate to the new environmental conditions. This research intends to inform resource managers on the most effective management practices to sustain coral reefs and assist in the design of effective marine reserve networks. Figueiredo and her students currently conduct research in South Florida and Okinawa, Japan.
The increasing demand for shark products, especially shark fins, has led to enormous fishing pressure on sharks worldwide, and considerable concern about the long-term health of shark populations. Mahmood Shivji, Ph.D., professor and director of the Guy Harvey Research Institute (GHRI) at NSU’s Oceanographic Center, is addressing these concerns by developing cutting-edge DNA-based forensic techniques and markers to rapidly identify shark carcasses, dried shark fins, and other products obtained from shark fisheries and fin markets. Using these forensic approaches, GHRI and its research partners (S. Clarke, Imperial College, UK, and the Wildlife Conservation Society) are conducting a survey of the world’s largest shark fin market in Hong Kong. This survey is aimed at establishing relationships between trade categories for fins and the shark species from which the fins were derived. These data, together with trade information available for some fin categories is also being applied to estimate the contribution of key pelagic shark species to the trade.
Coral reefs have declined drastically in recent decades as a result of disease, overfishing, pollution, sedimentation, physical breakage, and global climate change. Regulations and the establishment of marine protected areas have mitigated some of these factors that have led to the decline in coral reefs. Now researchers such as, Nicole Fogarty, Ph.D., assistant professor at NSU’s Oceanographic Center, are examining how corals can naturally restore reefs through successful reproduction. Fogarty studies fertilization and larval ecology to determine what factors influence corals’ early life stages. Additionally, she studies how two threatened species of corals can mate and produce a viable hybrid that appears to be increasing throughout the Caribbean while the parental species have declined.
Scientists are asked frequently asked about which coral reefs are important in terms of biodiversity --- the numbers and kinds of species that inhabit them. James Darwin Thomas, Ph.D., professor at NSU’s Oceanographic Center, is investigating small species of crustaceans that tell an evolutionary story about the history of how reefs have evolved and how particular groups of species are assembled in reef settings. He recently led a team of scientists to investigate the Madang Lagoon off Papua New Guinea’s (PNG) north coast. This small lagoon is the most diverse reef system ever documented and it’s in danger from human impact. Thomas’ research mission in PNG is timely because a multinational mining corporation is dumping thousands of tons of mining waste into the Ramu River that drains into the lagoon. Thomas and his team of scientists will assess certain groups of indicator species in the lagoon before the mining operation commences. Any subsequent adverse impacts from mining can then be measured. Thomas has since joined a similar expedition in the Philippines and will join a Dutch team of scientists to assess the reefs of St. Eustatius, Lesser Antilles in the Caribbean.
Coral reef ecosystems support a variety of marine species including fish, invertebrates, and crustaceans. Richard Spieler, Ph.D. professor at NSU’s Oceanographic Center, uses applied sciences and laboratory studies to examine coral reef restoration and coral reef fish distribution. He co-led a team of researchers with David Gilliam, Ph.D., assistant professor at NSU’s Oceanographic Center, that received the Gulf Guardian Award for their work surveying endangered reefs and fish species at the Veracruz Coral Reef System National Park in Mexico.
Through a holistic, systems biological approach, Travis Craddock, Ph.D., director, Clinical Systems Biology Lab and assistant professor, NSU’s Center for Psychological Studies leads a team that is benefiting the field of neuro-immune medicine. Current research efforts are focused on understanding immune dysfunction and autoimmunity from an integrated systems perspective. In particular, the team is investigating how subtle imbalances in the interplay between the immune system’s multiple components as well as its interactions with the endocrine and nervous systems may lead to complex disorders such as Gulf War Illness (GWI) and chronic fatigue syndrome (CFS). Illnesses such as these continue to defy a conventional one-piece-at-a-time approach. As none of the body’s systems function in isolation, new insight can be achieved by considering the immune, endocrine and nervous systems as part of an overarching and integrated whole. This comprehensive approach is at the very heart of systems biology: an emerging science in which context and interaction are key focal points.
Yair Levy, Ph.D., professor of information systems and cybersecurity, and director, NSU’s Center for e-Learning Security Research, in the newly formed NSU College of Engineering and Computing, is conducting research in the area of cybersecurity, privacy, advanced user authentication techniques, and e-learning security. Levy and his research team are incorporating multi-biometrics in e-examinations, developing innovative techniques to improve user authentications via multi-factor authentication, conducting national auditing of e-learning systems security, and developing proactive measures for cybersecurity threat mitigation. Their latest projects include a prototype of scenario-based iPad application to measure cybersecurity skills, a development of hierarchical index to examine privacy practices of pharmaceutical companies, as well as assisting small companies in South Florida and Puerto Rico mitigate common cybersecurity threats by assisting them to develop a roadmap for adoption of the National Institute of Standards and Technology (NIST) Cybersecurity Framework as a Risk Management Analysis (RMA) tool, especially in an effort to curb data-breaches.
Abusers seek to intensify the euphoric effects of opioids such as oxycodone by administering them in ways that provide faster absorption into their bloodstream. With oral pills, these include chewing before swallowing, crushing into powder in order to snort, or liquefying to inject the medication.
“Since abusers do not follow a standard protocol and use a wide range of unconventional ways to get to the opioid, no single technology can promise full deterrence to abuse,” said Omidian, professor at NSU’s College of Pharmacy. “This is why we decided to design technologies that can maximize drug entrapment when the medication is tampered for abuse. They can be used in both immediate and sustained-release formulations and at any drug concentration.”
Deterrent technologies are based on certain polymers that enhance the tablet strength and build up viscosity when such tablets are crushed and mixed with aqueous liquids.
Today, abuse-deterrent formulations are on the market for extended-release pain medications– effective for about 8 to 12 hours. The majority of short-term pain medications, however, do not include abuse-deterrent measures.
“Abuse-deterrent medications have helped apply the brakes to what was a fast and out-of-control rise in opioid abuse,” said David Mastropietro, Ph.D., assistant professor at the College of Pharmacy. “We must be mindful that these medications can only ‘deter’ abuse and must be used as part of a larger plan.”
Florida has been at the center of the nation’s prescription drug epidemic for the past decade, experiencing tremendous increases in prescription drug-related overdoses and mortality. NSU’s Center for Applied Research on Substance Use and Health Disparities (ARSH), at the College of Arts, Humanities, and Social Sciences, is a national leader in confronting this alarming public health problem by investigating prescription drug abuse and diversion. Center Director Steven P. Kurtz, Ph.D., and the ARSH team are leading research to stem this crisis from multiple perspectives: