Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products

NCT01964807 | Completed

• 3 other identifiers: P0052956P50CA180890136316
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Flow-mediated Dilation of the Brachial Artery

  Vascular function as measured by Flow-mediated Dilation of the Brachial Artery

  up to 3 hours after use of tobacco product

Secondary Outcomes (1)

• Heart Rate Variability (HRV)

  up to 3 hours after use of product.

Other Outcomes (1)

• Clot strength and plasma levels of interleukin-6 (IL-6) and 8-isoprostane

  up to 3 hours after use of product.

Study Arms (4)

Cigarette smokers

EXPERIMENTAL

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.

Other: Cigarette, NIDA test type with 16.6 mg nicotine; Other: Cigarette, NIDA test type with <0.45 mg nicotine; Other: Sham Smoking

Nonsmokers

EXPERIMENTAL

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.

Other: Secondhand cigarette smoke (SHS); Other: Conditioned, filtered air

Smokeless tobacco users

EXPERIMENTAL

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.

Other: Moist snuff; Other: Sham Moist Snuff

e-cigarette users

EXPERIMENTAL

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.

Other: Electronic cigarette with 18 mg/ml nicotine; Other: Electronic Cigarette with no nicotine; Other: Sham Smoking

Interventions

Cigarette, NIDA test type with 16.6 mg nicotine OTHER

Smoke a single cigarette for up to 10 minutes

Also known as: Cigarette

Cigarette smokers

Cigarette, NIDA test type with <0.45 mg nicotine OTHER

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

Also known as: Cigarette

Cigarette smokers

Electronic cigarette with 18 mg/ml nicotine OTHER

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

e-cigarette users

Electronic Cigarette with no nicotine OTHER

Use electronic cigarette with no nicotine for 30 minutes

e-cigarette users

Moist snuff OTHER

Use moist snuff for 30 minutes

Also known as: commercially available moist oral snuff

Smokeless tobacco users

Sham Smoking OTHER

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

Cigarette smokers; e-cigarette users

Secondhand cigarette smoke (SHS) OTHER

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

Also known as: Environmental Tobacco Smoke (ETS), ETS, SHS

Nonsmokers

Conditioned, filtered air OTHER

Exposure to conditioned, filtered air for 180 minutes

Also known as: Clean, filtered, temperature and humidity controlled air, Negative control for SHS exposure

Nonsmokers

Sham Moist Snuff OTHER

Chew gum for 30 minutes

Also known as: Chewing gum, Negative control for moist oral snuff use

Smokeless tobacco users

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Tobacco Use; Vaping

Interventions

Tobacco Products; Nicotine; Electronic Nicotine Delivery Systems; Tobacco Smoke Pollution; Temperature; Chewing Gum

Condition Hierarchy (Ancestors)

Behavior; Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoke; Particulate Matter; Complex Mixtures; Air Pollution; Environmental Pollution; Public Health; Environment and Public Health; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Peter Ganz, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 17, 2013
• Study Start: November 3, 2013
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)