Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adverse Effect of Other Agents Primarily Affecting the Cardiovascular System, Initial Encounter
- Sponsor
- University of California, San Francisco
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Flow-mediated Dilation of the Brachial Artery
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The overarching goal of this project is to develop a panel of cardiovascular risk biomarkers that can detect differences in the cardiovascular safety of various tobacco products, whether conventional, new or emerging, in order to help the FDA with the task of regulating them. This will be achieved through 4 aims:
Aim 1: Determine the relative contributions of nicotine and combustion products to the cardiovascular risk of active cigarette smoking.
Aim 2: Determine which cardiovascular risk biomarkers are affected by exposure to secondhand smoke.
Aim 3: Determine the cardiovascular risk of smokeless tobacco use.
Aim 4: Determine the cardiovascular risk of electronic cigarettes and the respective contributions of nicotine and electronic cigarette vapor.
Detailed Description
Cigarette smoking is a major cause of cardiovascular disease (CVD).1 In contrast, the cardiovascular risks of other popular tobacco products (smokeless tobacco), new tobacco products ( e-cigarettes) and proposed products (reduced nicotine cigarettes) are not adequately understood. The FDA will need information about the cardiovascular safety of these products to inform their regulatory decisions. While long-term clinical outcome studies of the cardiovascular risks of these tobacco products would be optimal, they take too long to provide the data that the FDA needs now. Disturbances in the function of vascular endothelium (the lining of arteries, which plays an important role in regulating vascular function) and the activation of the autonomic nervous system, as well as increased inflammation, oxidative stress and propensity to thrombosis (clotting), are key mechanisms in the progression of CVD and validated biomarkers of CVD risk. These biomarkers form the basis for our model to assess the CVD risks of tobacco product use and secondhand smoke exposure. We will conduct controlled, short-term exposures of human subjects to test products that provide a wide range of nicotine, particle, and other cardiovascular toxin concentrations to determine how these components associated with tobacco use adversely affect cardiovascular risk.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All Groups: Age 18-50
- •Can tolerate withholding their medications for two weeks at a time
- •Group 1: Active smokers
- •Group 2: Nonsmokers
- •Group 3: Active users of smokeless tobacco
- •Group 4: Active users of electronic cigarettes
- •Additional Inclusion Criteria for E-Cigarette Users:
- •Currently use ofe-cigarettes \> 5 times a day
- •Has used e-cigarettes for \>3 months
- •Additional Inclusion Criteria for Active Smokers: Currently smoke \>5 cigarettes per day ≥ 1 pack year
Exclusion Criteria
- •Exclusion Criteria for all subjects
- •Physician diagnosis of:
- •heart disease
- •hypertension
- •dyslipidemia
- •thyroid disease
- •renal or liver impairment
- •glaucoma.
- •Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder)
- •current use of more than two psychiatric medications
Outcomes
Primary Outcomes
Flow-mediated Dilation of the Brachial Artery
Time Frame: up to 3 hours after use of tobacco product
Vascular function as measured by Flow-mediated Dilation of the Brachial Artery
Secondary Outcomes
- Heart Rate Variability (HRV)(up to 3 hours after use of product.)