Trial record 15 of 28 for:    "secondhand smoke" | Open Studies

Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of California, San Francisco
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01964807
First received: October 4, 2013
Last updated: May 29, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Adverse Effect of Other Agents Primarily Affecting the Cardiovascular System, Initial Encounter
Other: Cigarette, NIDA test type with 16.6 mg nicotine
Other: Cigarette, NIDA test type with <0.45 mg nicotine
Other: Electronic cigarette with 18 mg/ml nicotine
Other: Electronic Cigarette with no nicotine
Other: Moist snuff
Other: sham smoking
Other: Secondhand cigarette smoke (SHS)
Other: Conditioned, filtered air
Other: sham moist snuff

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Flow-mediated dilation of the brachial artery [ Time Frame: up to 3 hours after use of tobacco product ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: up to 3 hours after use of product. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Clot strength and plasma levels of IL-6 and 8-isoprostane [ Time Frame: up to 3 hours after use of product. ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cigarette smokers
Will smoke 1 cigarette, 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
Smoke a single cigarette for up to 10 minutes
Other Name: Cigarette
Other: Cigarette, NIDA test type with <0.45 mg nicotine
Smoke a single low-nicotine cigarette for up to 10 minutes
Other Name: Cigarette
Other: sham smoking
Sham smoking or e-cigarette use consists of puffing on a drinking straw for 10 minutes
Experimental: 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.
Other: Secondhand cigarette smoke (SHS)
180-minute exposure to SHS generated by controlled dilution of smoke from machine-smoked cigarettes
Other Names:
  • environmental tobacco smoke
  • ETS
  • SHS
Other: Conditioned, filtered air
Exposure to conditioned, filtered air for 180 minutes
Other Names:
  • Clean, filtered, temperature and humidity controlled air
  • Negative control for SHS exposure
Experimental: 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.
Other: Moist snuff
Use moist snuff for 30 minutes
Other Name: commercially available moist oral snuff
Other: sham moist snuff
Chew gum for 30 minutes
Other Names:
  • Chewing gum
  • Negative control for moist oral snuff use
Experimental: 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.
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: sham smoking
Sham smoking or e-cigarette use consists of puffing on a drinking straw for 10 minutes

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:
  • 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 CO <10 ppm at each visit
  • Negative salivary cotinine test using a rapid-read, over the counter test with 30 ng/ml cutoff
  • Additional Exclusion Criteria for Nonsmokers:
  • More than 1 pack year smoking history
  • Quit smoking < 5 years ago
  • Ever a daily marijuana smoker
  • Smoked anything within the last 3 months
  • Additional Inclusion Criteria for Smokeless Tobacco Users:
  • Use of moist oral snuff > 5 times a day
  • Has used moist oral snuff for at least 0.5 years
  • Additional Exclusion Criteria for Smokeless Tobacco Users:
  • Current smoker
  • Quit smoking < 0.5 years ago
  • Additional Exclusion Criteria for E-Cigarette Users:
  • Current use of other tobacco products
  • Unable to hold marijuana for 1 week prior to each study visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964807

Contacts
Contact: Suzaynn F Schick, PhD 415-206-5904 suzaynn.schick@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Suzaynn F. Schick, PhD    415-206-5904    sschick@medsfgh.ucsf.edu   
Principal Investigator: Peter Ganz, M.D.         
Sub-Investigator: Suzaynn F. Schick, Ph.D.         
Sponsors and Collaborators
University of California, San Francisco
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Peter Ganz, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01964807     History of Changes
Other Study ID Numbers: P0052956, P50CA180890
Study First Received: October 4, 2013
Last Updated: May 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Cardiovascular
tobacco
cigarettes
secondhand cigarette smoke
SHS
smokeless tobacco
chewing tobacco
snus
electronic cigarettes
vapor
particles
oxidative stress
flow-mediated dilation
FMD

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 29, 2015