Treatment Trials

14 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
Description

The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids. The main questions it aims to answer are: * Do lower nicotine users actually consume less nicotine compared to higher nicotine users? * Do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users? * Do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? Researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect. Participants will: * Complete surveys on history of tobacco use, nicotine dependence and perception. * Use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment. * Complete daily questionnaires for mood and craving for two weeks in their natural environment. * Collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment. * Use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment. * Provide saliva, urine and blood samples in the lab at the end of each week.

COMPLETED
Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids
Description

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

COMPLETED
Developing E-liquid Product Standards (Sweet Spot Study)
Description

The Sweet Spot Study aims to evaluate the effect of e-liquids with nicotine varying in freebase (FB) levels and concentrations on the appeal of electronic cigarettes (ECs) in young adult EC users with minimal/no history of smoking and older adult smokers.

COMPLETED
Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
Description

This clinical trial studies the effect of free-base compared with nicotine salt based e-liquids on electronic cigarette (EC) puffing behavior, abuse liability, and deposition and absorption of nicotine in the respiratory tract and rate of uptake in the brain in current EC smokers. The results from this study may provide much needed scientific information to public health officials and regulators.

COMPLETED
Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems
Description

This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.

COMPLETED
Water Content in E-Liquids
Description

This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.

COMPLETED
Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers
Description

This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS).

COMPLETED
Short-Term Cardiovascular Effects of E-Cigarettes: Influence of E-Liquid pH
Description

This study will examine the short-term cardiovascular (CV) effects of e-liquid pH in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=21). The specific aim of the study is to assess the impact of changes in e-liquid pH on nicotine pharmacokinetics, cardiovascular, and subjective effects of e-cigarettes.

ACTIVE_NOT_RECRUITING
Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study
Description

This trial studies activity of time (pharmacokinetics), subjective effects, and abuse liability of nicotine salt-based vaping products with tobacco or e-liquids. This study aims to determine and compare the levels of nicotine delivered to the bloodstream from nicotine salt and free-base nicotine e-liquid solutions.

WITHDRAWN
Vaping High vs. Low Nicotine E-Liquid
Description

This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.

COMPLETED
Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors
Description

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

Conditions
COMPLETED
Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes
Description

This is an observational, crossover design that will examine the pharmacokinetics and pharmacodynamics of impact of smoking tobacco cigarettes or vaping the JUUL electronic cigarette.

COMPLETED
Impact of Flavors on Nicotine Perception and Self-Administration Via E-cigarettes
Description

The goal of this application is to test whether menthol and fruit flavors impact e-cigarette use through dissociable mechanisms and exert their effects differentially across nicotine doses.

COMPLETED
Electronic Cigarette Use During Pregnancy
Description

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.