Study Results
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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COMPLETED
NA
110 participants
INTERVENTIONAL
2019-10-01
2023-04-10
Brief Summary
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Detailed Description
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Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Chronic TC smoker
Chronic TC smokers will use, in a randomized, crossover fashion with a 4 week washout, a 1) TC with nicotine (own brand), 2) research TC with very low level nicotine, and 3) a straw (control)
control
sham control
TC with nicotine (own brand)
smoke a TC
research TC with very low level nicotine
smoke a research TC with very low level nicotine
Non-user
Non- users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)
EC with nicotine
Use an EC with nicotine for up to 30 minutes
EC without nicotine
Use an EC without nicotine for up to 30 minutes
control
sham control
Chronic EC user
Chronic EC users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)
EC with nicotine
Use an EC with nicotine for up to 30 minutes
EC without nicotine
Use an EC without nicotine for up to 30 minutes
control
sham control
Interventions
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EC with nicotine
Use an EC with nicotine for up to 30 minutes
EC without nicotine
Use an EC without nicotine for up to 30 minutes
control
sham control
TC with nicotine (own brand)
smoke a TC
research TC with very low level nicotine
smoke a research TC with very low level nicotine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
45 Years
ALL
Yes
Sponsors
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Tobacco Related Disease Research Program
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Holly R Middlekauff
Principal Investigator
Locations
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UCaliforniaLA
Los Angeles, California, United States
Countries
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Other Identifiers
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19-000452
Identifier Type: -
Identifier Source: org_study_id
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