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Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products

NCT ID: NCT01964807

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-03

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Adverse Effect of Other Agents Primarily Affecting the Cardiovascular System, Initial Encounter

Keywords

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Cardiovascular tobacco cigarettes secondhand cigarette smoke SHS smokeless tobacco chewing tobacco snus electronic cigarettes vapor particles oxidative stress flow-mediated dilation (FMD) FMD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cigarette smokers

Will smoke 1 cigarette, National Institute of Drug Abuse (NIDA) test type with 16.6 mg nicotine; 1 cigarette, NIDA test type with \<0.45 mg nicotine; perform sham smoking by puffing on a drinking straw. Each intervention will last 10 minutes, and each will take place one time, on one of 3 study visits, in random order.

Group Type EXPERIMENTAL

Cigarette, NIDA test type with 16.6 mg nicotine

Intervention Type OTHER

Smoke a single cigarette for up to 10 minutes

Cigarette, NIDA test type with <0.45 mg nicotine

Intervention Type OTHER

Smoke a single low-nicotine cigarette for up to 10 minutes

Sham Smoking

Intervention Type OTHER

Sham smoking or e-cigarette use consists of puffing on a drinking straw for 10 minutes

Nonsmokers

Will undergo secondhand cigarette smoke (SHS) exposure and conditioned, filtered air exposure. Each intervention will last 180 minutes, and each will take place one time, on one of 2 study visits, in random order.

Group Type EXPERIMENTAL

Secondhand cigarette smoke (SHS)

Intervention Type OTHER

180-minute exposure to SHS generated by controlled dilution of smoke from machine-smoked cigarettes

Conditioned, filtered air

Intervention Type OTHER

Exposure to conditioned, filtered air for 180 minutes

Smokeless tobacco users

Will use 1 pouch of commercially available moist oral snuff and will chew gum (sham moist snuff). Each intervention will last 30 minutes, and each will take place one time, on one of 2 study visits, in random order.

Group Type EXPERIMENTAL

Moist snuff

Intervention Type OTHER

Use moist snuff for 30 minutes

Sham Moist Snuff

Intervention Type OTHER

Chew gum for 30 minutes

e-cigarette users

Will use one electronic cigarette with 18 mg/ml nicotine, one electronic cigarette with no nicotine, and will perform sham smoking by puffing on a drinking straw. Each intervention will last 10 minutes, and each will take place one time, on one of 3 study visits, in random order.

Group Type EXPERIMENTAL

Electronic cigarette with 18 mg/ml nicotine

Intervention Type OTHER

Use electronic cigarette with 18 mg/ml nicotine for 30 minutes

Electronic Cigarette with no nicotine

Intervention Type OTHER

Use electronic cigarette with no nicotine for 30 minutes

Sham Smoking

Intervention Type OTHER

Sham smoking or e-cigarette use consists of puffing on a drinking straw for 10 minutes

Interventions

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Cigarette, NIDA test type with 16.6 mg nicotine

Smoke a single cigarette for up to 10 minutes

Intervention Type OTHER

Cigarette, NIDA test type with <0.45 mg nicotine

Smoke a single low-nicotine cigarette for up to 10 minutes

Intervention Type OTHER

Electronic cigarette with 18 mg/ml nicotine

Use electronic cigarette with 18 mg/ml nicotine for 30 minutes

Intervention Type OTHER

Electronic Cigarette with no nicotine

Use electronic cigarette with no nicotine for 30 minutes

Intervention Type OTHER

Moist snuff

Use moist snuff for 30 minutes

Intervention Type OTHER

Sham Smoking

Sham smoking or e-cigarette use consists of puffing on a drinking straw for 10 minutes

Intervention Type OTHER

Secondhand cigarette smoke (SHS)

180-minute exposure to SHS generated by controlled dilution of smoke from machine-smoked cigarettes

Intervention Type OTHER

Conditioned, filtered air

Exposure to conditioned, filtered air for 180 minutes

Intervention Type OTHER

Sham Moist Snuff

Chew gum for 30 minutes

Intervention Type OTHER

Other Intervention Names

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Cigarette Cigarette commercially available moist oral snuff Environmental Tobacco Smoke (ETS) ETS SHS Clean, filtered, temperature and humidity controlled air Negative control for SHS exposure Chewing gum Negative control for moist oral snuff use

Eligibility Criteria

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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
* Currently use ofe-cigarettes \> 5 times a day
* Has used e-cigarettes for \>3 months

* Use of moist oral snuff \> 5 times a day
* Has used moist oral snuff for at least 0.5 years

Exclusion Criteria

* 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
* 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 counter test with 30 ng/ml cutoff
* More than 1 pack year smoking history
* Quit smoking \< 5 years ago
* Ever a daily marijuana smoker
* Smoked anything within the last 3 months
* Current smoker
* Quit smoking \< 0.5 years ago
* Current use of other tobacco products
* Unable to hold marijuana for 1 week prior to each study visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Ganz, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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P50CA180890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

136316

Identifier Type: OTHER

Identifier Source: secondary_id

P0052956

Identifier Type: -

Identifier Source: org_study_id