Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products

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

Interventions

OTHER

Cigarette, NIDA test type with 16.6 mg nicotine

Smoke a single cigarette for up to 10 minutes

OTHER

Cigarette, NIDA test type with <0.45 mg nicotine

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

OTHER

Electronic cigarette with 18 mg/ml nicotine

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

OTHER

Electronic Cigarette with no nicotine

Use electronic cigarette with no nicotine for 30 minutes

OTHER

Moist snuff

Use moist snuff for 30 minutes

OTHER

Sham Smoking

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

OTHER

Secondhand cigarette smoke (SHS)

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

OTHER

Conditioned, filtered air

Exposure to conditioned, filtered air for 180 minutes

OTHER

Sham Moist Snuff

Chew gum for 30 minutes

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Food and Drug Administration (FDA)

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Peter Ganz, M.D. · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-11-03

Primary Completion

2021-05-31

Completion

2021-05-31

Countries

• United States

Study Locations