MedicalResearch.com Interview with:
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Mr. Brian Tefft[/caption]
Mr. Brian C. Tefft
Senior Research Associate
AAA Foundation for Traffic Safety
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In December 2012, a new law took effect in Washington state that effectively legalized the possession and use of small amounts of marijuana by adults aged 21 years and older for recreational purposes, and also created a legal limit for driving under the influence of marijuana such that having a concentration of 5.00 nanograms or greater of delta-9-tetrahydrocannabinol (THC, the main psychoactive chemical in marijuana) per milliliter of whole blood while driving in the state of Washington is
per se driving under the influence.
Data from population-based surveys indicate that the proportion of Washington state residents who report using marijuana increased after this law took effect; however, not much was known about the impact of this new law on traffic safety in the state. To investigate the traffic safety impact of the new law, we examined drug test results from drivers involved in motor vehicle crashes that occurred in years 2010 – 2014 in Washington and resulted in the death of at least one person within 30 days of the crash. Specifically, we looked at the proportion of all drivers involved in fatal crashes who had detectable THC in their blood at or shortly after the time of the crash, which generally suggests that the driver had used
marijuana within the past few hours.
Results showed that from 2010 through 2013, approximately 8-9% of drivers in fatal crashes each year were positive for THC, and that proportion was basically flat from 2010 through 2013. In 2014, the proportion basically doubled, to 17%. Our modelling suggests that an increasing trend in the proportion of drivers who were positive for THC began in late 2013, about 9-10 months after the new law took effect.
Prof. Ellen Meara[/caption]
Professor Ellen Meara, PhD
Professor
The Dartmouth Institute for Health Policy and Clinical Practice
MedicalResearch.com: What is the background for this study?
Response: Responding to a fourfold rise in death rates, between 2006 and 2012, states collectively enacted 81 laws restricting prescribing and dispensing of prescription opioids. Jill Horwitz, PhD, JD, said “states hoped passing a range of laws might help. So they are enacting small fixes — forbidding patients from “doctor-shopping,” and requiring doctors to use tamper-resistant prescription forms. They are also implementing major efforts such as prescription drug monitoring programs (PDMPs) — online databases that allow law enforcement and clinicians to monitor prescriptions.”
Dr. Stefania Papatheodorou[/caption]
Stefania I. Papatheodorou, MD, PhD
Cyprus International Institute for Environmental and Public Health
Limassol, Cyprus
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Marijuana is the most commonly used illicit drug in the United States. Despite increasing use and acceptance of marijuana, both medically and recreationally, gaps remain in our knowledge regarding potential health effects.
In this study, we aimed to evaluate associations between recent marijuana use, exhaled Nitric Oxide (eNO) and pulmonary function. We performed a cross-sectional study of 10,327 US adults participating in the National Health and Nutrition Examination Survey (NHANES) in the years 2007 to 2012.
Exhaled Nitric Oxide was lower among participants who used marijuana in the past 0 to 4 days and those who last used marijuana 5 to 30 days before the examination compared with the never users. FEV1 was higher among participants who used marijuana within 0 to 4 days before the examination compared with those who never used marijuana, while FVC was higher in both past and current marijuana users compared with never users. The FEV1/FVC ratio was significantly lower among those who used marijuana in the 0 to 4 days before the examination compared with never users.
Dr. Hannah Carliner[/caption]
Hannah Carliner, ScD MPH
Post Doctoral Fellow in Substance Abuse Epidemiology
Mailman School of Public Health
Columbia University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Carliner: We know from previous research that traumatic experiences in childhood can have far-reaching effects on the mental and physical health of adults, including increasing the risk for substance use disorders. There is a particularly strong body of evidence about this concerning exposure to child abuse and various other forms of family dysfunction and violence.
However, no previous studies have examined a wider range of traumatic childhood experiences and their link to experimentation with different kinds of drugs in adolescence. While some studies have interviewed adults about initiation of drug use at this age, those results are not as reliable as interviewing teens directly.
Using a nationally-representative sample of almost 10,000 non-institutionalized U.S. adolescents, we therefore determined that childhood trauma was associated with lifetime drug use in teens-- not only with clinically-significant disordered drug use, but even with just trying drugs one time.
Dr. Hsien-Yen Chang[/caption]
Hsien-Yen Chang PhD
Assistant Scientist
Johns Hopkins Bloomberg School of Public Health
Department of Health Policy & Management
Center for Drug Safety & Effectiveness
MedicalResearch.com: What is the background for this study?
Dr. Chang: Prescription opioid addiction and non-medical use are significant public health problems, responsible for about 44 daily overdose deaths in the United States. Although there are no magic bullets to address these issues, policy makers play an important role in shaping regulatory, payment and public health policies to reduce opioid-related injuries and deaths. For example, state policy-makers in the United States have used prescription drug monitoring programs (PDMPs) and “pill mill” laws to address the prescription opioid epidemic. While there is growing evidence regarding the effect of these approaches on opioid sales, little is known about how they affect specific groups of prescribers. This is important, as approximately 20% of U.S. physicians are responsible for prescribing 80% of all opioid analgesics. Therefore, in this study we evaluated the impact of PDMPs and pill mill laws on the clinical practices of high-risk prescribers in Florida, such as their total number of prescription-filling patients with an opioid prescription. Furthermore, we also characterized the concentration of opioid volume and prescriptions among this group of prescribers as well as how the policies of interest impacted these measures.
Prof. Claire Roberts[/caption]
Professor Claire Roberts PhD
Robinson Research Institute
Adelaide University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Roberts: Our research aimed to identify novel risk factors for the four main complications of pregnancy;
Dr. Richard Mangano[/caption]
Richard M. Mangano, PhD
Chief Scientific Officer at Relmada Therapeutics
Dr. Mangano has extensive experience leading global R&D programs in both large and small pharmaceutical companies including positions in discovery and clinical research at Hoffmann-La Roche, Lederle Laboratories, Wyeth Research and Adolor Corporation. He served as acting Therapeutic Area Director for Neuroscience at Wyeth before joining Adolor as Vice President of Clinical Research and Development. Dr. Mangano’s expertise includes multiple IND/CTC submissions and NDA/MAA approvals in psychiatry, neurology and gastrointestinal therapeutic areas. Dr. Mangano is also an adjunct professor in the Department of Pharmacology and Physiology at the Drexel University School of Medicine. He lectures in the Drug Discovery and Development Program and in the Psychiatry Department’s Resident Training Program. He has authored 30 peer reviewed publications and over 120 abstracts and presentations. Dr. Mangano holds a B.S degree in Chemistry from Iona College and a PhD degree in Biochemistry from Fordham University. Prior to joining the pharmaceutical industry, he was a research faculty member of the Maryland Psychiatric Research Institute at the University of Maryland School of Medicine.
Dr. Mangano discusses the opioid addiction and the development of abuse-resistant medications.
MedicalResearch.com: What is the background for the development of abuse-resistant medications? How extensive is the problem of opioid addiction?
Dr. Mangano: Recognizing the growing incidence of opioid abuse, misuse, and overdose in the United States, pharmaceutical companies, with the guidance of the FDA, are developing products that can mitigate abuse, while recognizing the importance of maintaining the availability of opioid analgesics for the millions of patients in this country who suffer from pain.
Approximately two million people in the U.S. are addicted to opioids. The market for products that treat opioid dependence has grown significantly due to the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin use, and the growing number of physicians treating opioid dependence.
One of our product candidates, REL-1028 (BuTab), is a proprietary formulation of buprenorphine designed to treat both opioid addiction and moderate to severe chronic pain. Although there is the potential for addiction to buprenorphine, the risk is lower because it is a “partial agonist” of the mu opioid receptor compared with “full agonist” opioids like heroin, morphine, oxycodone, and hydrocodone. As a result, products containing buprenorphine, such as BuTab, should have reduced risk of abuse and physical dependence and would be controlled in Schedule III of the Controlled Substances Act (as opposed to the more restrictive Schedule II). We are also considering a formulation that would include an opioid antagonist that would not interfere with analgesia when taken orally as prescribed but would block the action of buprenorphine if it were to be inhaled or injected.
Dr. William Eggleston[/caption]
William Eggleston, PharmD
Fellow in Clinical Toxicology/Emergency Medicine
Upstate Medical University
Upstate New York Poison Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Eggleston: The case series describes two deaths associated with loperamide abuse with supportive post-mortem findings. It adds to the growing body of literature reporting cardiac toxicity after loperamide abuse and demonstrates the deadly consequences. It also highlights the growing trend of loperamide abuse amongst opioid addicted patients looking to get high or stave off withdrawal symptoms.
MedicalResearch.com: What should readers take away from your report?
Dr. Eggleston: Readers should recognize that loperamide is an OTC opioid medication that acts similarly to morphine or heroin in the body after high doses. The drug is easily abused due to its low cost, ease of accessibility, legal status, and lack of social stigma associated with its possession. Most importantly, loperamide is a cardiac toxin that causes conduction disturbances in high doses and can produce deadly dysrhythmias.
Dr. Shelly B. Flagel[/caption]
Shelly B. Flagel, PhD
Molecular and Behavioral Neuroscience Institute
Department of Psychiatry
University of Michigan, Ann Arbor, MI 48109
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Flagel: We used a unique genetic animal model to examine individual differences in addiction liability. This model of selectively bred rat lines allowed us to examine the brains of “addiction-prone” and “addiction-resilient” rats before and after they were exposed to cocaine. I
mportantly, even though all rats were exposed to the same amount of drug, only a certain subset exhibited addiction-like behavior. We focused our neurobiological analyses on two molecules that have been previously implicated in response to drugs of abuse – the dopamine D2 receptor and fibroblast growth factor (FGF2). We examined gene expression and the epigenetic regulation of these molecules and found that low levels of FGF2 in the core of the nucleus accumbens, a brain region known for regulating motivated behavior, may protect individuals from becoming addicted; whereas low levels of D2 in this brain region may predispose individuals to addiction.
Further, this is the first study to show that epigenetic modulation of these molecules may be a predisposing factor and that, the epigenetic regulation of D2 may be especially important in susceptibility to relapse.
