Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors
Status
Completed
Conditions
Smoking
Treatments
Other: Low nicotine level e-liquid
Other: NNC Spectrum Cigarette
Other: Tobacco and non-tobacco e-liquid flavors
Other: Moderate nicotine level e-liquid
Other: Tobacco Flavors
Other: VLNC Spectrum Cigarette
Study type
Interventional
Funder types
Other
NIH
Identifiers
NCT03185546
1U54DA031659-01 (U.S. NIH Grant/Contract)
U54DA031659-06 (U.S. NIH Grant/Contract)
IRB00047676
Details and patient eligibility
About
Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.
Enrollment
156 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Smokers who have tried vaping multiple times.
- Generally good health.
Exclusion criteria
- If female, currently pregnant, trying to become pregnant or breastfeeding.
- Planning to quit smoking.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
156 participants in 8 patient groups
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors
Experimental group
Description:
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Treatment:
Other: Moderate nicotine level e-liquid
Other: NNC Spectrum Cigarette
Other: Tobacco Flavors
NNC cigarette + low nicotine e-liquid + tobacco flavors
Experimental group
Description:
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Treatment:
Other: NNC Spectrum Cigarette
Other: Tobacco Flavors
Other: Low nicotine level e-liquid
NNC cigarette + moderate nicotine e-liquid + variety flavors
Experimental group
Description:
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
Treatment:
Other: Moderate nicotine level e-liquid
Other: NNC Spectrum Cigarette
Other: Tobacco and non-tobacco e-liquid flavors
NNC cigarette + low nicotine e-liquid + variety flavors
Experimental group
Description:
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
Treatment:
Other: NNC Spectrum Cigarette
Other: Low nicotine level e-liquid
Other: Tobacco and non-tobacco e-liquid flavors
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Experimental group
Description:
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Treatment:
Other: Moderate nicotine level e-liquid
Other: Tobacco Flavors
Other: VLNC Spectrum Cigarette
VLNC cigarette + low nicotine e-liquid +tobacco flavors
Experimental group
Description:
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
Treatment:
Other: Tobacco Flavors
Other: Low nicotine level e-liquid
Other: VLNC Spectrum Cigarette
VLNC cigarette + moderate nicotine e-liquid + variety flavors
Experimental group
Description:
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
Treatment:
Other: Moderate nicotine level e-liquid
Other: Tobacco and non-tobacco e-liquid flavors
Other: VLNC Spectrum Cigarette
VLNC cigarette + low nicotine e-liquid + variety flavors
Experimental group
Description:
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
Treatment:
Other: Low nicotine level e-liquid
Other: Tobacco and non-tobacco e-liquid flavors
Other: VLNC Spectrum Cigarette
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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