Nicotine clinical trials at University of California Health
11 in progress, 6 open to eligible people
VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)
open to eligible people ages 18 years and up
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). This clinical trial will evaluate the safety, tolerability and pharmacokinetics (the concentration of drug in the blood over time) of VRDN-001 in healthy volunteers and in patients with TED. Study participants with TED will also be evaluated over time for changes in their signs and symptoms of TED compared to their baseline measurements.
at UCSF
Electronic Hookah and Endothelial Cell Function
open to eligible people ages 21-39
Electronic nicotine delivery systems (ENDS) are a new rapidly growing global epidemic. More recently, electronic (e-) hookahs, have increased in popularity in the United States, with the greatest uptake by young female adults, who endorse marketing claims that these products are safer alternatives to traditional flavored hookah tobacco smoking. Unlike other ENDS such as e-cigarettes, e-hookah bowls are used through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol, glycerin, and flavorings-to pass through a water-filled basin, potentially altering the vapor, before it is inhaled through the user's mouth. Contributing to e-hookah bowls' popularity is the belief that the flavored smoke is detoxified as it passes through the water-filled basin, rendering e-hookah a safer tobacco alternative. However, an e-hookah bowl delivers flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. The objective of this project is to investigate the effects of e-hookah bowl inhalation on endothelial function, vascular biomarkers and volatile compounds; and molecular mechanisms underlying e-hookah induced endothelial injury using freshly harvested human endothelial cells with a specific role of nicotine. In a cross-over study design, the investigators will first assess endothelial function measured by brachial artery flow-mediated dilation and markers of oxidative stress and inflammation in 18 young healthy hookah smokers 21-39 years old, before and after two separate 30-minute e-hookah bowl inhalation sessions using one brand of nicotine-containing and nicotine-free e-hookah liquid and, for control comparison, before and after sham hookah smoking. Then, in freshly harvested venous endothelial cells the investigators will assess nitric oxide bioavailability, and expression of markers of inflammation and oxidative stress before and after the sessions. To compare specific exposures across conditions, the research team will measure changes in plasma nicotine, and highly specific urinary mercapturic acid metabolites of acrolein and benzene. This proposed study will provide critical scientific data on the impact of e-hookah inhalation on vascular health and mechanisms of exposure on known cardiac risk factors. Results will provide critical data to the FDA to inform the development of regulations specific to hookah.
at UCLA
Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)
open to eligible people ages 21-70
This is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.
at UCSF
Short-Term Cardiovascular Effects of E-Cigarettes: Influence of E-Liquid pH
open to eligible people ages 21-70
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.
at UCSF
THC Crossover Study
open to eligible people ages 21 years and up
This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.
at UCSF
Nicotine to Reverse Age-related Auditory Processing Deficits
open to eligible people ages 18-85
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.
at UC Irvine
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Sorry, not yet accepting patients
In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.
at UCSF
Financial Incentives for Smoking Treatment II
Sorry, accepting new patients by invitation only
Financial incentives for motivating changes in health behavior, particularly for smoking and other morbid habits, are increasingly being tested by health insurers, employers, and government agencies. However, in using incentive programs for smoking cessation, key unanswered structural and theoretical questions remain regarding their effectiveness, acceptability to patients, and economic sustainability. This trial aims to advance the science and implementation of financial incentives for smoking cessation interventions among high-risk, hospitalized smokers. The investigators will pursue two specific aims: 1) comparing the impact of three approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life and 2) comparing the short-term and long term return on investment of using goal directed and outcome-based financial incentives to promote smoking cessation.
at UCLA
New Treatment for Alcohol and Nicotine Dependence
Sorry, in progress, not accepting new patients
This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.
at UCSD
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Sorry, in progress, not accepting new patients
Social media based intervention to support teens in their efforts to quit vaping.
at UCSF
Clinical Pharmacology of Marijuana-Tobacco Co-administration
Sorry, not yet accepting patients
This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.
at UCSF
Our lead scientists for Nicotine research studies include Pamela Ling, MD Robert M Anthenelli, MD Fan-Gang Zeng, PhD Gideon St.Helen Neal Benowitz, MD.
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