Trial record 5 of 77 for:    "Tobacco, Smokeless" | Open Studies

Cardiovascular Assessment of the Effects of Tobacco and Nicotine Delivery Products

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 16, 2013
Last verified: December 2013
  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: Cigarettes, NIDA test type with 16.6 mg nicotine per
Other: Cigarette, NIDA test type with <0.45 mg nicotine per
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) exposure
Other: Conditioned, filtered air exposure
Other: Chewing gum, no nicotine

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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 ]
    10 minutes, 30 minutes and 3 hours after use of tobacco product


Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: up to 3 hours after use of product. ] [ Designated as safety issue: No ]
    10 minutes, 30 minutes and 3 hours after use of product.


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 ]
    10 minutes, 30 minutes and 3 hours after use of product.


Biospecimen Retention:   Samples With DNA

plasma, serum, urine, saliva


Estimated Enrollment: 88
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)
Groups/Cohorts Assigned Interventions
Active cigarette smokers
Healthy 21-50 year old. Currently smoke >5 cigarettes per day ≥ 1 pack year. Will smoke 1 cigarette, NIDA test type, with 16.6 mg nicotine, 1 cigarette, NIDA test type, with <0.45 mg nicotine and perform sham smoking by puffing on a drinking straw. Each "intervention" will last 10 minutes. Each "intervention" will take place one time, on one visit. Each visit will include only one test condition.
Other: Cigarettes, NIDA test type with 16.6 mg nicotine per
Other Name: Cigarette
Other: Cigarette, NIDA test type with <0.45 mg nicotine per Other: sham smoking
Sham smoking or e-cigarette use consists of puffing on a drinking straw
nonsmokers
Healthy 21-50 year old. Will be exposed to secondhand cigarette smoke at 350 micrograms total particulate material per cubic meter air and to conditioned, filtered air. Each "intervention" will last 180 minutes. Each "intervention" will take place one time, on one visit. Each visit will include only one test condition.
Other: Secondhand cigarette smoke (SHS) exposure
Secondhand cigarette smoke generated by controlled dilution of smoke from machine-smoked cigarettes
Other Names:
  • environmental tobacco smoke
  • ETS
  • SHS
Other: Conditioned, filtered air exposure
This is negative control for secondhand smoke exposure in Arm 2, health nonsmokers
Other Name: Clean, filtered, temperature and humidity controlled air
Active users of smokeless tobacco

Healthy 21-50 year old. Use of moist oral snuff > 5 times a day. Has used moist oral snuff for at least 0.5 years.

Will use 1 pouch of commercially available, moist oral snuff and will chew gum. Each "intervention" will last 30 minutes. Each "intervention" will take place one time, on one visit. Each visit will include only one test condition.

Other: Moist snuff Other: Chewing gum, no nicotine
Negative control for moist oral snuff use.
Other Name: Juicy Fruit
Active users of e-cigarettes

Healthy 21-50 year old. Currently use of e-cigarettes > 5 times a day. Has used e-cigarettes for >3 months.

Will use an electronic cigarette with 18 mg nicotine, an electronic cigarette, with no nicotine and will perform sham smoking by puffing on a drinking straw. Each "intervention" will last 10 minutes. Each "intervention" will take place one time, on one visit. Each visit will include only one test condition.

Other: Electronic Cigarette, with 18 mg/ml nicotine Other: Electronic Cigarette, with no nicotine Other: sham smoking
Sham smoking or e-cigarette use consists of puffing on a drinking straw

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
Sampling Method:   Probability Sample
Study Population

Active smokers Nonsmokers Active users of smokeless tobacco Active users of electronic cigarettes

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
Study First Received: October 4, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
smokeless tobacco
Cardiovascular
tobacco
cigarettes
secondhand cigarette smoke
SHS
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 October 20, 2014