View clinical trials related to Tobacco Use.
Filter by:Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.
Some smokers who try e-cigarettes transition completely from cigarettes to e-cigarettes, but others continue to use both products, or abandon e-cigarettes and return completely to cigarettes. One factor that likely impacts these tobacco use patterns is the e-cigarette device used. The majority of e-cigarettes purchased today are one of two "types:" customizable tanks or pods. These e-cigarette types differ from each other in critical ways, like nicotine delivery and sensory characteristics, that are likely to impact use by influencing the relative reinforcement value of the product. The present study will be a randomized trial investigating the impact of e-cigarette device type on reinforcement value and use among current smokers. Current smokers (n=100) will be randomly assigned to either a control group that does not receive an e-cigarette or one of two e-cigarette types: a customizable tank, or a pod. The impact of device type on relative reinforcement value will be assessed using a choice task. Participants will also take home their assigned e-cigarette for a three-week sampling period. Primary outcomes include relative reinforcement value (choices to smoke in the lab-based choice task), cigarette smoking behavior (cigarettes smoked per day during sampling), and uptake (e-cigarette puffing episodes per day during sampling).
This study will be a single-center, controlled, open-label, parallel study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to an ENDS Investigational Product (IP) product with 4.8% nicotine over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.
An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)
A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations
This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).
This is a randomized, open-label, crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the investigational products (IPs) by healthy subjects.
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients.