292 Clinical Trials for Various Conditions
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 clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.
Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however their long-term health effects are unknown. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of cardiovascular and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products. This study will produce the most informative evidence to date on how long-term ENDS use affects cardiovascular and pulmonary health.
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory.
The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.
To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.
The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.
Electronic Nicotine Delivery Systems (ENDS) use remains prevalent among young adults, and many have high interest in quitting, yet research on effective intervention is lacking. A mobile health (mHealth) intervention that translates effective smoking cessation materials and pharmacotherapy may be a promising avenue for intervention. The initial phase of the proposed study uses a pilot study to evaluate a novel mHealth intervention for young adult ENDS and dual product (ENDS and combustible cigarette) users.
The goal of this research is to evaluate the efficacy of cannabidiol (CBD) in reducing cigarette smoking. Although there are safe and effective treatments for smoking cessation, not everyone who attempts smoking cessation is successful, even with these treatments. Relapse rates are high, leaving a need for new approaches. Despite justification to evaluate CBD for this indication, human research on the topic is scant. Larger, more extended studies are warranted and essential. The investigators will recruit participants from CRI-Help, Inc., a substance abuse treatment program in North Hollywood, where residents who indicate the desire to stop smoking are prohibited from using other cannabis products which would affect recruitment. The aims of this study are: 1. Evaluate the effects of CBD on changes in cigarette use throughout and following the trial. 2. Exploratory Aims. Measure plasma concentrations of CBD, N-arachidonoyl-ethanolamine (anandamide) and 2-arachidonoylglycerol (2-AG) throughout the trial. Participants who meet eligibility criteria will take part in a 56-day treatment phase during which they receive the study medication under supervision (CBD or placebo twice daily) and complete questionnaires on side effects, withdrawal, craving and mood symptoms. Blood, breath, and urine tests will also be performed throughout the study. Participants who complete the treatment will also be assessed at 1-month and 3-month follow up visits.
The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a dime-sized area of the skin in otherwise healthy young (18-24yrs) chronic e-cigarette users. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, we also draw blood from the subjects to measure circulating factors that may contribute to cardiovascular health and examine markers of inflammatory activation. We will also collect urine from female participants to measure estradiol.
The goal of this clinical trial is to test the effects of social media use on e-cigarette use in young adults who use e-cigarettes. The main questions it aims to answer are: * Does reducing social media use change young adults' e-cigarette use? * Does reducing social media use change things such as young adults' mental health and what they see on social media? Participants will complete surveys and submit screenshots showing how much time they spend on social media. Researchers will compare young adults who reduce their social media use to young adults who use social media as usual, to see if their e-cigarette use differs.
The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products at the same time (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by e-cigarettes is more effective for quitting both products. The study will also compare the effect of treatment on health-related biomarkers. All participants will receive varenicline, a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e., links to text-based support, self-change booklet). Varenicline helps to reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.
The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.
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.
Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. To accomplish these aims, a theory-driven parallel, controlled 2-arm randomized clinical trial will be conducted with young adult e-cigarette users (approximately N = 50). Outcomes are attentional bias to e-cigarette cues and abstinence outcomes including nicotine dependence, and arousal/urges for e-cigarette use.
This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.
The aim of this study is to determine if graphic messages prevent future vaping use among African American and Latino adolescents. The images have been developed in a user-design model and include four main themes: health reward, financial reward, self-efficacy, and social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping among African American and Latino adolescents.
This trial studies how well an enhanced tobacco intervention protocol (ETIP) works compared to standard treatment in helping head and neck and lung cancer patients starting treatment to reduce cigarette use. ETIP is an evidence-based tobacco cessation program including specialized one-to-one and telehealth counseling, drug therapy, nicotine replacement therapy, and frequent patient follow up. ETIP may help reduce smoking and improve cessation in patients with head and neck squamous cell cancer or non-small cell lung cancer.
The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use
The goal of this research is to understand the potential impact of two new FDA strategies to ensure the availability of safer Alternative Nicotine Delivery Systems (ANDS) and to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, this research will examine how well ANDS and very low nicotine cigarettes (VLNCs) can work alone or in combination with the current strategy of providing a safe source of nicotine via nicotine replacement medications to reduce use of combustible cigarettes, in real-world settings. The investigators will enroll 180 daily adult smokers who are not planning to quit smoking within the next 30 days into this mixed design study. Participants will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNC cigarettes; 2) Juul e-cigarettes (with nicotine); or 3) no alternative product. Participants receiving an alternative product (VLNC or e-cigarettes) will be asked to use it for 4 weeks (Weeks 1 through 4). During Weeks 2 and 4 all participants will be asked to switch from their cigarettes to use only study products (i.e., Juul e-cigarettes, VLNCs, or no alternative product) and to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order. During Weeks 1 through 4, participants will use a smartphone to record, in the moment, each time they use their own cigarettes or any alternative product. For a random daily subset of use events, participants will complete additional questions about the internal and external context of their use (e.g., affect, any restrictions on smoking) and their response to use (e.g., withdrawal alleviation, taste, satisfaction). Using these data, the investigators will also examine the effects of these products on the rewarding value of smoking and possible mechanisms driving such behavior (e.g., withdrawal alleviation, satisfaction, taste). This research will provide critical information regarding the potential impact of providing cigarettes with non-addictive levels of nicotine and safe ANDS, with or without nicotine replacement, in real-world settings on smokers' use of their usual cigarettes and other outcomes. Information on the short-term effects of products that could be accessible in the future will provide data that could inform regulatory policy decisions regarding the public health impact of safe ANDS and non-addictive cigarettes.
This study aims to establish the feasibility and acceptability of a project designed to investigate the impact of electronic cigarette use on combustible cigarette smoking and smoking-related factors among smokers with psychiatric disorders, a high-risk population, who are not yet ready to quit smoking. All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8 weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Adolescents are an important vulnerable population to consider as the FDA moves toward a nicotine reduction policy. Such a policy, which would mandate a reduction of nicotine in all commercially available cigarettes, has the potential to transform public health and greatly reduce the toll of tobacco-related death and disease. Yet, data on the effects of such a policy on cigarette use among adolescents are lacking. Further, the advent of e-cigarettes and the popularity of alternative tobacco products have fundamentally altered the current landscape of nicotine delivery, and these products are widely used by adolescents. Although adolescent cigarette use is at an all-time low in the U.S., this reduction has been mirrored by an increase in e-cigarette use, and multiple tobacco product (MTP) use is the most common pattern of use in youth. Adolescent MTP users are more likely to be dependent on nicotine and to have begun using tobacco earlier than their single-product using peers. Thus, MTP-using youth differ from youth who solely smoke cigarettes in meaningful ways that have implications for responses to a nicotine reduction regulatory policy. In adults, longer-term studies have demonstrated that very low nicotine content (VLNC) cigarette exposure results in fewer cigarettes smoked and reduced toxicant exposure; however, increased use of alternative tobacco products has also been reported. No studies to date have examined the effects of VLNC cigarettes on MTP use or toxicant exposure in youth. This study will use real-time, smartphone-based ecological momentary assessment (EMA) and laboratory-based assessments to: (1) investigate the effects of cigarette nicotine reduction on cigarette and MTP use, (2) assess the influence of cigarette nicotine reduction on the harms associated with tobacco use, including nicotine and toxicant exposure, respiratory symptoms, perceived health risk and nicotine dependence, and (3) use a combination of laboratory and real-time assessment to investigate the effects of nicotine reduction on changes in withdrawal, craving, and the reinforcing efficacy of cigarettes to characterize the mechanisms by which VLNC use may affect behavior. Overall, this project will help determine the effects of VLNC cigarettes on real-world tobacco use behavior and indices of tobacco-related harm in adolescents, and examining the mechanisms through which nicotine reduction in cigarettes may effect such changes.
The study aims to develop tobacco modules to be included in an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) and to determine the feasibility and preliminary efficacy of the updated version of S4E in an urban youth-centered community health clinic in Southeast Michigan.
The investigators aim to (1) establish a methodology for the evaluation of the biodistribution of radio-labeled nicotine following e-cigarette use, (2) determine the oral/pulmonary distribution of nicotine following e-cigarette use, and (3) determine the lowest required dose using the new digital PET/CT technology to provide detailed or accurate oral/pulmonary distribution data following e-cigarette use. Potential participants will be identified using advertisements such as brochures and online social media postings. After participants are identified, their eligibility will be determined using survey tools. All eligible participants will first have a screening visit at the WCIBMI for study participation. During this initial visit, subjects will be informed about the study in detail, and the relevant consent form will be reviewed and signed. If the participant agrees to participate, they will go through a full dress rehearsal. Up to 10 volunteers will only participate in the dress rehearsal. All other volunteers (30) will have a dress rehearsal without radiation exposure on day 1, and then on a second day, they will participate in the full imaging study using 11C-nicotine. During the imaging study, S-nicotine will be labeled with 11C and placed in the cartridge of an e-cigarette. There will be two dose groups: (A) 3 mCi dosage or (B) 9 mCi doses. The investigators intend to use dose level A; however, if it does not lead to the expected results, an alternate dose level as an option is needed, which is the 9 mCi (B) dose level. Subjects will take a maximum of 10 puffs (1 puff per 30 seconds) from the e-cigarette while positioned in the PET/CT system. Dynamic PET/CT imaging will be performed for a maximum of 60 minutes following inhalation. The subject will be placed in the PET camera in order to generate axial images of the following regions: head/neck (e.g., brain, oral cavity, and throat) and thorax (e.g., trachea, lungs). From the PET/CT images, quantitative radioactivity deposition will be determined, and the biodistribution and uptake/clearance will be evaluated. PET data will be acquired in listmode and subsequently used for simulation to determine the potentially lowest dose feasible using the next generation digital PET/CT technology.
Aim 1: To compare the overall toxicant exposure in pregnant women who use electronic cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who smoke conventional cigarettes. Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes. Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.
This is an observational, crossover study that will be examine use behaviors, chemical exposures, and biological effects of SREC compared to TC use in subjects confined to a research ward setting.
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.
Investigating the acute effects of a single use E-Cigarette upon vascular health.
The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes
This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible tobacco product dual users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors (location, activity, social cues) associated with each episode of use. Participants will also complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction with the e-cigarette experience during the study.