Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products (NCT01964807) | Clinical Trial Compass
CompletedNot Applicable
Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products
United States81 participantsStarted 2013-11-03
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* asthma
* heart disease
* hypertension
* dyslipidemia
* thyroid disease
* diabetes
* 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
* Pregnancy or breastfeeding (by history)
* Alcohol, opiate, cocaine, amphetamine or methamphetamine dependence within the past 5 years
* BMI \> 35 and \< 18
* Current opiate, cocaine, amphetamine or methamphetamine use (by history or urine test)
* Occupational exposure to smoke, dusts and fumes
* Concurrent participation in another clinical trial
* Unable to communicate in English
* Additional Exclusion Criteria for Active Smokers:
* Unable to hold marijuana for 1 week prior to each study visit.
* Exhaled carbon monoxide (CO) \<10 ppm at each visit
* Negative salivary cotinine test using a rapid-read, over the…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Flow-mediated Dilation of the Brachial Artery
Timeframe: up to 3 hours after use of tobacco product