31 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if low nicotine eliquids work to reduce exposure to nicotine, in addicted ecig users, without increasing consumption of other harmful constituents. The main questions it aims to answer are: * Does switching to lower nicotine eliquids change the vaping behavior of addicted ecig users? * Does switching to lower nicotine eliquids reduce the amount of nicotine consumed? Researchers will compare ecig users who switch from a higher to lower nicotine eliquid to a control group that does not switch. Participants will: * Complete history of tobacco use and nicotine addiction questionnaires * Switch from higher to lower nicotine product or control for 15 days * Complete daily questionnaires to report craving, mood and nicotine withdraw For one full day under each nicotine condition, participants will: * record puffing behavior using a topography monitor * wear a sensorized shirt that measures the depth and duration of inhalation, and * collect a saliva sample at the end of each day
The study is focused on investigating the mechanisms involved in microvascular health in subjects that use e-cigarettes frequently. To explore microvascular health, different techniques and compounds. For one of the tests, iontophoresis, the drug's use will be stored and handled as described by the approved IND and non-IDS plan.
This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.
To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.
Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health
The purpose of this study is to find out if a new intervention helps teenagers who vape nicotine quit vaping. The program involves two parts: giving rewards (also called contingency management \[CM\]) and online video counseling (also called cognitive behavioral therapy \[CBT\]).
Over the past 10 years, electronic cigarettes (e-cigarettes, EC) have been commercialized as a "less harmful" alternative to traditional cigarettes.1,2 However, e-cigarettes are believed to cause pulmonary epithelial, endothelial and vascular dysfunction, and to cause murine phenotypes similar to those of human COPD. Recently, "spiked" vape juice has been linked to severe lung damage. Unfortunately, the effects of e-cigarettes on the human lungs are still poorly understood, especially in healthy young adults. Therefore, establishing the health effects of e-cigarettes in humans is of paramount importance to guide medical and regulatory decision making. Its widespread use and immense popularity among teenagers and young adults have caused major concern given potentially significant addictive and detrimental long-term health effects.
E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.
While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults.
This research will explore the feasibility of leveraging social network analysis to identify 6th grade opinion leaders to lead a school-based e-cigarette intervention. The project will be conducted for 6th graders in 8 schools in the Pittsburgh area.
The use of the Invite Only VR, with the aim to prevent the initiation of e-cigarette use in teens by increasing their knowledge, decreasing their intentions to use e-cigarettes, influencing their harm perceptions and attitudes associated with e-cigarettes, and increasing self-efficacy associated with refusing peers involving e-cigarettes.
The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL). The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit. The main questions it aims to answer are: * Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use? * Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day? Researchers will assign participants to either BREATHE Free curriculum or usual care. Participants will: * Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line * BREATHE Free group will attend 12 group meetings held on the university campus * All participants will answer interview questions related to tobacco use, character strengths and resilience * Expired Carbon Monoxide (CO) will be assessed in all participants.
This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes will be assessed as mechanisms.
This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, adult smokers (N=200) will attend two laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation) and smoke their own cigarettes.
The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.
The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.
This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the safety profile of 3 mg cytisinicline administered TID for 12 weeks.
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th or 10th graders in two high schools in Pittsburgh, Pennsylvania.
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.
The aim of this study is to test intervention components to help young adults quit vaping. A 2x2 factorial design will be used where all participants receive quitline-delivered behavioral phone counseling, and components to be tested are a digital intervention (with text and online cessation support) and nicotine replacement therapy (NRT). The research questions and hypotheses for this study are: 1. Which components and combinations of intervention yield the greatest success rates for exclusive vaping cessation among young adult exclusive e-cigarette users? H1: The complete condition (NRT + digital) will yield significantly higher rates of cessation compared to the control condition (quitline only). 2. Does 8 weeks of nicotine replacement therapy (NRT) improve initial cessation outcomes relative to no NRT. H2: Providing NRT will yield significantly higher quit rates compared to the No NRT condition. 3. Do tailored text-messages and online support during cessation improve initial cessation outcomes relative to no digital content? Are young adult vapers engaged with and satisfied with digital cessation tools? H3: Digital support will yield significantly higher quit rates compared to no digital support. H4: Higher engagement in digital content will be associated with higher cessation success rates.
The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). The investigators will recruit participants using national advertising strategies. All treatment will be provided remotely in order to increase treatment access and comply with current COVID-19 restrictions.
This study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode
This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly high peak nicotine concentrations immediately before smoking the cigarette. This reduces the rewarding effect of smoking, in part from receptor desensitization that occurs following nicotine exposure, which reduces the response to a subsequent dose of nicotine, and in part from satiating the drive to smoke; 2) the use of the JUUL will become associated with the same cues that elicit smoking, thereby promoting the substitution of JUUL use for CC use; and 3) ad libitum nicotine intake from the JUUL and its rewarding effects will be maximized because, unlike CC, they will be experienced after a period of nicotine deprivation. Thus, despite a lower per-puff nicotine dose relative to CC, the pharmacologic impact and reinforcing effect will be maximized. The study will evaluate two flavors (Mint and Virginia Tobacco), randomly assigned, to determine if flavor assignment (similar to the subjects' usual brand of CC or different than the subjects usual brand CC) has an effect on the success of this reconditioning procedure.
To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the population. Further, the objective is to administer additional surveys to assess which methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping, alcohol intake, and food intake are preferred by the study population.
Patients in addiction treatment have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes among patients in addiction treatment.
This randomized pilot clinical trial studies the effects of electronic cigarettes on the lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and Drug Administration (FDA) and other government regulators with important information, which may help in developing future regulations to make electronic cigarettes safer.
The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.
This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were utilized: a single controlled administration and a short-term ad lib use. As smoking behaviors vary from smoker to smoker, a controlled administration allows for some standardization of nicotine "dose" for each of the study products to better understand their uptake characteristics as well as urge reduction achieved under controlled conditions. Further evaluation under ad lib product use conditions provides insight into product self-administration behaviors that will allow subjects to achieve acceptable levels of urge reduction. Comparisons were made to evaluate differences between blu™ formulations as well as to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.
The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract in e-cigarette users, cigarette smokers, and non-smokers.