Chemicals and Drugs Commons^™

Smoking Cessation Treatments Varenicline (Chantix®️), Nrts, And Nicotine Dependence, Marley Vea Devoss

Biology: Student Scholarship & Creative Works

Varenicline was approved in 2006 by the FDA as an effective smoking cessation drug. Varenicline was designed to bind with α4β2 nicotinic acetylcholine receptors (nAChR) to work as both an agonist and antagonist. Other drugs like nicotine replacement therapies (NRTs) have also contributed to the decreasing rate of active smokers in the United States. The mechanisms of varenicline and its role in addiction are reviewed in this paper. With NRTs and recent trends in electronic smoking devices, nicotine dependence is still a cause for concern due to studies connecting nicotine with cell proliferation and heart disease.

Market Claims And Efficacy Information In Direct‐To‐Consumer Prescription Drug Print Advertisements, Kathryn J. Aikin Phd, Kevin R. Betts Phd, Aysha Keisler Phd, Kathryn Schaefer Ziemer Phd

United States Food and Drug Administration: Publications

This study examined the impact of “New” and “#1 Prescribed” market claims and quantitative efficacy information on perceptions of a hypothetical prescription drug in a direct‐to‐consumer (DTC) print advertisement. We examined two market claims (New and #1 Prescribed), two efficacy levels (higher and lower), and a control condition without this information. Participants with diabetes were randomized to review one ad version and asked their perceptions of the ad's message, the drug's benefits, side effects and risks, doctors' opinions about the drug, and behavioral intention to use the drug, as well as recall and recognition of drug benefits and risks. Results …

Youth Perception Of Harm And Addictiveness Of Tobacco Products: Findings From The Population Assessment Of Tobacco And Health Study (Wave 1), David R. Strong, Karen Messer, Martha White, Yuyan Shi, Madison Noble, David B. Portnoy, Alexander Persoskie, Annette R. Kaufman, Kelvin Choi, Charles Carusi, Maansi Bansal-Travers, Andrew Hyland, John Pierce

United States Food and Drug Administration: Publications

Purpose: We provide a US national assessment of youth perceptions of the harm and addictiveness of six separate tobacco products, identifying a continuum of perceived harm associated with a range of products in relation to patterns of current use, former use, and susceptibility to use tobacco products.

Methods: We evaluated youth respondents (N=13,651) ages 12–17 from Wave 1 (2013–2014) of the Population Assessment of Tobacco and Health (PATH) Study. Analyses (2015–2016) focused on refining mea- sures of perceived harm for each product and delineating youth characteristics (demographic, tobacco use status) associated with beliefs about the harmfulness and addictiveness of tobacco …

Associations Of Risk Factors Of E-Cigarette And Cigarette Use And Susceptibility To Use Among Baseline Path Study Youth Participants (2013–2014), Michael D. Sawdey, Hannah R. Day, Blair Coleman, Lisa D. Gardner, Sarah E. Johnson, Jean Limpert, Hoda T. Hammad, Macieji L. Goniewicz, David B. Abrams, Cassandra A. Stanton, Jennifer L. Pearson, Annette R. Kaufman, Heather L. Kimmel, Cristine D. Delnevo, Wilson M. Compton, Maansi Bansal-Travers, Raymond S. Niaura, Andrew Hyland, Bridget K. Ambrose

United States Food and Drug Administration: Publications

Introduction: Improved understanding of the distribution of traditional risk factors of cigarette smoking among youth who have ever used or are susceptible to e-cigarettes and cigarettes will inform future longitudinal studies examining transitions in use.

Methods: Multiple logistic regression analysis was conducted using data from youth (ages 12–17 years) who had ever heard of e-cigarettes at baseline of the PATH Study (n = 12,460) to compare the distribution of risk factors for cigarette smoking among seven mutually exclusive groups based on ever cigarette/e-cigarette use and sus- ceptibility status.

Results: Compared to committed never users, youth susceptible to e-cigarettes, cigarettes, or …

Selection And Consumption Of Lunches By National School Lunch Program T Participants, Janet G. Peckham, Jaclyn D. Kropp, Thomas A. Mroz, Vivian Haley-Zitlin, Ellen M. Granberg

United States Food and Drug Administration: Publications

The Healthy, Hunger-Free Kids Act of 2010 requires schools participating in the National School Lunch Program (NSLP) to offer a variety of healthy food options each day. Using digital photography data collected from two suburban elementary schools in the spring of 2013, we examine NSLP participant's selection and consumption of all five NSLP lunch components ((1) milk, (2) vegetable, (3) fruit, (4) meat/meat alternate (MA), and (5) grain). We use logit regressions to analyze the selection of the various lunch components by race/ethnicity, gender, grade, and household income level. In addition, ordinary least squares regressions are used to analyze the …

Examining The Role Of Menthol Cigarettes In Progression To Established T Smoking Among Youth, James Nonnemaker, Shari P. Feirman, Anna Macmonegle, Bridget K. Ambrose, Kia J. Jackson, Megan J. Schroeder, Alexandria A. Smith, William Ridgeway, Olga Rass

United States Food and Drug Administration: Publications

Background: Menthol, a flavoring compound added to cigarettes, makes cigarettes more appealing to youth and inexperienced smokers and increases cigarettes' abuse liability. However, limited studies are available on menthol's role in smoking progression.

Methods: To assess the association between menthol in cigarettes and progression to established smoking, we used five waves of data from the Evaluation of Public Education Campaign on Teen Tobacco Cohort Study, a nationally representative longitudinal survey of U.S. youth conducted as part of “The Real Cost” evaluation. We used discrete time survival analysis to model the occurrence of two event outcomes—progression to established, current smoking and …

U.S. Adult Perceptions Of The Harmfulness Of Tobacco Products: Descriptive T Findings From The 2013–14 Baseline Wave 1 Of The Path Study, Geoffrey T. Fong, Tara Elton-Marshall, Pete Driezen, Annette R. Kaufman, K. Michael Cummings, Kelvin Choi, Jonathan Kwan, Amber Koblitz, Andrew Hyland, Maansi Bansal-Travers, Charles Carusi, Mary E. Thompson

United States Food and Drug Administration: Publications

Introduction: This study is the first nationally representative survey of U.S. adults (18+) to examine perceptions of the relative harms of eight non-cigarette tobacco products.

Methods: Data are from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study Adult Questionnaire, a nationally representative study of 32,320 adults in the United States conducted from September 2013 to December 2014.

Results: 40.7% of adults believed that electronic cigarettes were less harmful than cigarettes, and 17.8% of adults believed that hookah was less harmful than cigarettes. Those less knowledgeable about the health risks of smoking were more likely to believe …

Photoassisted Synthesis Of Complex Polyheterocycles Via Esipt-Driven Dearomative Intramolecular Cycloadditions, Dmitry Kuznetsov

Electronic Theses and Dissertations

This research is focused on the development of novel photoassisted synthetic methodologies that provide straightforward access to complex and diverse libraries of polyheterocycles from modularly assembled precursors. All methods are based on the dearomative cycloadditions between two components: (i) o-azaxylylenes, generated by the excited-state intramolecular proton transfer, and (ii) tethered arene groups.

We have demonstrated the synthetic utility of four new photoinduced processes that yield complex products amenable for post-photochemical modifications:

• [4+4] Cycloaddition of o-azaxylylenes to 1,3,4-oxadiazoles with subsequent dinitrogen extrusion. This reaction furnishes compounds outfitted with epoxide fragments, which undergo ring-openings with various nucleophiles; furthermore, the oxidized products …

Use Of Beta-Antagonists Or Hmg-Coa Reductase Inhibitors For Cardioprotection During Chemotherapy In Oncology Patients, Nicole Streich

Physician Assistant Scholarly Project Posters

Over the years, oncologists are better able to fight cancer and have increased cancer survival, but we are also finding that these lifesaving therapies can affect the heart and other parts of the body in a negative way. Chemotherapy is excellent at destroying cancer cells, but it also causes collateral damage to other healthy cells. There are certain chemotherapeutic agents that are known to cause cardiotoxicity. Currently we are monitoring the heart function of the patients who are receiving these cardiotoxic drugs prior to starting the chemotherapy as well as during and after treatment. However, there are currently no recommendations …

Analyzing Brain Sample Via Hplc Method, Neethu Mathew

BIO4950: Internship in Biology

This paper aims to investigate the principle methodology behind extraction and detection of an anti-cancer drug from brain samples via the high performance liquid chromatography (HPLC) method. In order to assess the efficiency of the methodology carried out in the Rumbaugh-Goodwin Institute of Cancer Research (RGI), numerous peer-reviewed journals and articles were analyzed over the duration of this internship. They were filtered on the basis of inclusion of keywords, date written, peer-reviewed credibility, and similarity to RGI’s research. The literature that has been chosen to be reviewed includes studies that present similar methodologies or test drugs with similar functions. From …

The Effects Of Medical Cannabis Use Among Adults With Chronic Pain: An Integrative Review Of The Literature, Bridget A. Asevedo

Honors Undergraduate Theses

The purpose of this integrative literature review was to understand the effects of medical cannabis for chronic pain management in adults. Anecdotal reports suggest the use of medical marijuana as a pain management therapy could be an alternative to opioids and other medications which have long term consequences. Potential uses span the health care continuum, from prescribed outpatient symptom management, to acute care, extended care, home care, and hospice treatment settings. The methodology included a review and synthesis of relevant research articles from 2012 to 2018, written in the English language. The findings suggest medical cannabis has the potential of …

Can Nanotechnology Be The Leading Method In Detecting And Treating Cerebral Tumors?, Daniel D. Singh, Zuri Jules-Culver

OUR Journal: ODU Undergraduate Research Journal

Nanotechnology refers to the manipulation or design of materials and structures with desired features in the 1nm–1000 nm size range. The blood brain barrier (BBB) is a major obstacle that drugs must overcome in order to reach tumor cells. The role of this barrier is to transport essential nutrients while protecting and regulating the internal environment. Nanoparticles have been shown to transport drugs through this barrier and accumulate in tumor cells. This is significant since nanoparticles are drug carriers allowing chemotherapeutic drugs to accumulate in target areas (Sun et al., 2017). This is possible because they are able to be …

Improving Dopamine Monitoring With Ncam And The Effects Of Intranasal Oxytocin On Dopamine Signaling In The Rat Brain, Darren Earl Ginder

EWU Masters Thesis Collection

Dopamine (DA) is a neurohormone highly involved in learning and memory. Oxytocin (OXT), another neurohormone, has also been implicated in learning and memory. Fast-scan cyclic voltammetry (FSCV) is a method used for the real-time examination of DA neurotransmission in the brain. Implanting FSCV electrodes is an invasive technique that likely results in an inflammatory response (i.e. gliosis) that can restrict FSCV recording of DA signals. Neural cell adhesion molecule (NCAM) may reduce gliosis and potentially improve the ability of FSCV electrodes to monitor DA signaling. Chapter 1 Methods: FSCV electrodes were coated with NCAM and implanted in the rat brain. …

Development Of A Chemical Genetic Screen To Identify Compounds That Enhance Laromustine Cytotoxicity, Xiaoou Wang

Honors Theses

Laromustine is a chemotherapeutic sulfonylhydrazine prodrug used in clinical trials against acute myeloid leukemia. Though laromustine showed some success in clinical trials, more experiments are needed to understand the hematological toxicity and the molecular mechanisms of patients’ resistance. This project aims to develop a strategy to identify compounds synergistic with laromustine in cultured leukemia cells from a library of 450 FDA-approved compounds through a forward chemical genetic screen. To optimize the screen, the cell seeding density, doubling time, and dose response curves were determined. The optimized concentration of HL60 cells in these experiments was determined to be between 25,000 and …

Understanding Structure-Activity Relationship Of Synthetic Cathinones (Bath Salts) Utilizing Methylphenidate, Barkha J. Yadav

Theses and Dissertations

Synthetic cathinones are stimulant drugs of abuse that act at monoamine transporters e.g. the dopamine transporter (DAT) as releasing agents or as reuptake inhibitors. More than >150 new synthetic cathinones have emerged on the clandestine market and have attracted considerable attention from the medical and law enforcement communities.

threo-Methylphenidate (tMP) is an FDA approved drug for the treatment of ADHD and narcolepsy, which also acts as a DAT reuptake inhibitor and is widely abused. tMP and synthetic cathinones share some structural similarities and extensive structure-activity relationship (SAR) studies on tMP have been conducted. However, much less is known about the …

Regorafenib Enhances Lethality Of Sildenafil And Curcumin In Colorectal Cancer Cells, Kervin Benjamin Owusu

Theses and Dissertations

In the United States, more than 130,000 people will be diagnosed with colorectal cancer (CRC) each year and an estimated 50,000 people will die from the disease. Standard of care (SOC) therapies for CRC combine multiple cytotoxic chemotherapeutic drugs. These combinations have varying degrees of effectiveness and can often result in significant patient morbidity. For second recurrence patients, the multi-kinase inhibitor, regorafenib, is an approved agent, but is often poorly tolerated at current doses. In the current study, we propose to develop therapeutic regime of combining agents with modest toxicity profiles: curcumin and sildenafil with regorafenib. Using clinically achievable enterohepatic …

Pharmacologic Profiling Of Novel Compounds Via Fluorometric Analyses Of Monoamine Transporter Responses, Ashkhan Hojati

Theses and Dissertations

In humans and other organisms, monoaminergic systems are crucial in neuronal function and behavior. The monoamine transporters (MATs), which can be found on the presynaptic plasma membrane of neurons in the central nervous system (CNS), are crucial in the regulation of neurotransmitter concentration in the synaptic cleft. As the duration and concentration of neurotransmitters in the cleft affect further downstream signaling responses, these proteins are important targets for both understanding neuronal physiology and compounds of interest. Multiple theories exist proponing the contribution of MATs to a variety of mental and neurological disorders, including depression. This theory establishes that depression is …

Myopia Outcome Study Of Atropine In Children (Mosaic): Design And Methodology, Saoirse Mccrann, Daniel Ian Flitcroft, John Butler, James Loughman

Articles

Purpose

The Myopia Outcome Study of Atropine in Children (MOSAIC) aims to explore the efficacy, safety, acceptability and mechanisms of action of 0.01% atropine for myopia control in a European population.

Methods

MOSAIC is an investigator-led, double-masked, placebo-controlled, randomised clinical trial investigating the efficacy, safety and mechanisms of action of 0.01% atropine eyedrops in myopic progression management. During phase 1 of the trial, 250 children aged 6-16 years with progressive myopia apply eye drops once nightly in both eyes from randomisation to month 24. No treatment is given during phase 2 from month 24 to 36 (washout period) for those …

The Potential Of Biobanked Liquid Based Cytology Samples For Cervical Cancer Screening Using Raman Spectroscopy., D. Traynor, S. Duraipandian, R. Bhatia, K. Cuschieri, C. M. Martin, J. J. O'Leary, Fiona Lyng

Articles

Patient samples are unique and often irreplaceable. This allows biobanks to be a valuable source of material. The aim of this study was to assess the ability of Raman spectroscopy to screen for histologically confirmed cases of Cervical Intraepithelial neoplasia (CIN) using biobanked liquid based cytology (LBC) samples. Two temperatures for long term storage were assessed; 80°C and -25°C. The utility of Raman spectroscopy for the detection of CIN was compared for fresh LBC samples and biobanked LBC samples. Two groups of samples were used for the study with one group associated with disease (CIN 3) and the other associated …

At Risk Alcohol Consumption With Smoking By National Background: Results From The Hispanic Community Health Study/Study Of Latinos, Frank C. Bandiera, Eliseo J. Pérez-Stable, Folefac Atem, Raul Caetano, Denise C. Vidot, Marc D. Gellman, Elena L. Navas-Nacher, Jianwen Cai, Gregory Talavera, Neil Schneiderman, Robert Kaplan

United States Food and Drug Administration: Publications

Introduction: Tobacco smoking and binge or excess drinking are unhealthy behaviors that frequently co-occur. Studies of Hispanics/Latinos have mostly been of Mexican Americans although there are substantial differences in smoking and drinking by heritage background. Associated with co-use by 5 subpopulations.

Methods: Cross-sectional data of 16,412 Hispanics/Latinos from Miami, the Bronx, Chicago and San Diego collected between 2008 and 2011 as part of the HCHS/SOL were analyzed. Smoking and alcohol consumption and demographic data were measured by self-report. Prevalence of smoking and alcohol consumption and co-use were reported. Logistic regression models examined the odds of co-use of smoking and binge …

Comparing Methods For Clinical Investigator Site Inspection Selection: A Comparison Of Site Selection Methods Of Investigators In Clinical Trials, Nicholas Hein, Elena Rantou, Paul Schuette

United States Food and Drug Administration: Publications

Background During the past two decades, the number and complexity of clinical trials have risen dramatically increasing the difficulty of choosing sites for inspection. FDA’s resources are limited and so sites should be chosen with care.

Purpose To determine if data mining techniques and/or unsupervised statistical monitoring can assist with the process of identifying potential clinical sites for inspection.

Methods Five summary-level clinical site datasets from four new drug applications (NDA) and one biologics license application (BLA), where the FDA had performed or had planned site inspections, were used. The num- ber of sites inspected and the results of the …

Impact Of Contemporary Low Dose Aspirin Use And Cardiovascular Disease, Pratik Sharma, Ramona Stone

Public Health Sciences Student Work

No abstract provided.

A Complete Approach To Predict Biodistribution Of Nanomaterials Within Animal Species From In-Vitro Data, Edward Price

Electronic Theses and Dissertations

Smart drug-design for antibody and nanomaterial-based therapies allows for optimization of drug efficacy and more efficient early-stage pre-clinical trials. The ideal drug must display maximum efficacy at target tissue sites, but to track and predict distribution to these sites, one must have a mechanistic understanding of the kinetics involved with the individual cells of the tissue itself. This process can be tracked through biological simulations coupled with in-vitro approaches, which result in a rapid and efficient in-depth understanding of drug transport within tissue vasculature and cellular environment. As a result, it becomes possible to predict drug biodistribution within live animal …

Mechanisms And Thermodynamics Of The Influence Of Solution-State Interactions Between Hpmc And Surfactants On Mixed Adsorption Onto Model Nanoparticles, Salin Gupta Patel

Theses and Dissertations--Pharmacy

Nanoparticulate drug delivery systems (NDDS) such as nanocrystals, nanosuspensions, solid-lipid nanoparticles often formulated for the bioavailability enhancement of poorly soluble drug candidates are stabilized by a mixture of excipients including surfactants and polymers. Most literature studies have focused on the interaction of excipients with the NDDS surfaces while ignoring the interaction of excipients in solution and the extent to which the solution-state interactions influence the affinity and capacity of adsorption. Mechanisms by which excipients stabilize NDDS and how this information can be utilized by formulators a priori to make a rational selection of excipients is not known.

The goals of …

Toward An Enzyme-Coupled, Bioorthogonal Platform For Methyltransferases: Probing The Specificity Of Methionine Adenosyltransferases, Tyler D. Huber

Theses and Dissertations--Pharmacy

Methyl group transfer from S-adenosyl-l-methionine (AdoMet) to various substrates including DNA, proteins, and natural products (NPs), is accomplished by methyltransferases (MTs). Analogs of AdoMet, bearing an alternative S-alkyl group can be exploited, in the context of an array of wild-type MT-catalyzed reactions, to differentially alkylate DNA, proteins, and NPs. This technology provides a means to elucidate MT targets by the MT-mediated installation of chemoselective handles from AdoMet analogs to biologically relevant molecules and affords researchers a fresh route to diversify NP scaffolds by permitting the differential alkylation of chemical sites vulnerable to NP MTs that are unreactive to …

Hematologic Safety Of Chronic Brain-Penetrating Erythropoietin Dosing In App/Ps1 Mice, Jiahong Sun, Joshua Yang, Kathrine Whitman, Charlene Zhu, David H. Cribbs, Ruben J. Boado, William M. Pardridge, Rachita K. Sumbria

Pharmacy Faculty Articles and Research

Introduction: Low blood-brain barrier (BBB) penetration and hematopoietic side effects limit the therapeutic development of erythropoietin (EPO) for Alzheimer's disease (AD). A fusion protein of EPO and a chimeric monoclonal antibody targeting the mouse transferrin receptor (cTfRMAb) has been engineered. The latter drives EPO into the brain via receptor-mediated transcytosis across the BBB and increases its peripheral clearance to reduce hematopoietic side effects of EPO. Our previous work shows the protective effects of this BBB-penetrating EPO in AD mice but hematologic effects have not been studied. Herein, we investigate the hematologic safety and therapeutic effects of chronic cTfRMAb-EPO dosing, …

Targeting Lipoprotein Biogenesis: Considerations Towards Antimicrobials, Toufic El Arnaout, Tewfic Soulimane

Articles

Decades have passed without approval of a new antibiotic class. Several companies have recently halted related discovery efforts because of multiple obstacles. One promising route under research is to target the lipoprotein maturation pathway in light of major recent findings and the virulence roles of lipoproteins. To support the future design of selective drugs, considerations and priority-setting are established for the main lipoprotein processing enzymes (Lgt, LspA, and Lnt) based on microbiology, biochemistry, structural biology, chemical design, and pharmacology. Although not all bacterial species will be similarly impacted by drug candidates, several advantages make LspA a top target to pursue …

Investigating The Effect Of Sodium Benzoate On Immune Cells And Microbial Populations In The Small Intestine Of Murine Species., Shelby Pedigo

Senior Honors Projects, 2010-2019

Dietary ingredients can influence the mucosal surface morphology and mucosal immunity of the gastrointestinal tract. Additional health concerns and behavioral changes have been attributed to the consumption of foods containing preservatives and additives. Sodium benzoate (SB) is a commonly used bacteriostatic in food and beverages. This study investigates the effects of SB on the gut bacteria and mucosal health in the gastrointestinal tract of laboratory mice. The extent of lymphocytic infiltration in intestinal villi and granular density of Paneth cells in the ileum were used as evaluators of mucosal immunity. Adult C57BL/6 mice were randomly assigned to two …

The Chemical Analysis And Biological Activities Of The Secondary Metabolites From Dalea Mollis And Dalea Albiflora, Nicholas Peter Hansen

All Master's Theses

Multidrug resistance has increased since the introduction of drugs used to prevent growth and kill microorganisms in a host. This has caused a worldwide search to discover new drugs effective against microorganisms. Mechanisms of drug resistance include, but are not limited to, the production of biofilms and efflux pumps. Efflux pumps prevent antimicrobial drugs from reaching their biological target, so the coordinated use of efflux pump inhibitors and antimicrobial drugs has been identified as a potential treatment for multidrug-resistant microorganisms. The secondary metabolites of Dalea mollis and Dalea albiflora were tested against multidrug-resistant (MDR) and engineered strains of the fungi …

The Impact Of Medical Marijuana On The Opioid Crisis, Carl David Eastep

Physician Assistant Scholarly Project Posters

• The opioid crisis dictates the need for research into alternative treatments for acute and chronic pain.

• Comprehensive literature review was conducted to determine if medical marijuana might play a role in the treatment of acute and chronic pain.

• The addiction profiles of medical marijuana and prescription opiates were compared along with the adverse effects and quality of life.

• No use for medical marijuana for the treatment of acute pain.

• Likely some benefits from medical marijuana for chronic pain.

• Addictive profile

• Marijuana – marijuana withdrawal syndrome.
• Prescription Opiates – highly addictive

• Adverse …