Clinical trial NCT03185546: Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors
Official title: Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
vaping
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-06-14
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Cigarettes Smoked Per Day
timeFrame: Week 10 through Week 12
Secondary outcomes:
measure: Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)
timeFrame: Baseline - Week 12
measure: Number of Subjects With Smoke Free Days
timeFrame: Baseline-Week 12
Other outcomes:
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Baseline-Week 12
measure: Number of Days Using Assigned Vaping Device
timeFrame: Baseline-Week 12
measure: Cigarette Evaluation Scale
timeFrame: Baseline-Week 12
measure: Mercapturic Acids
timeFrame: Baseline-Week 12
measure: Fagerstrom Nicotine Dependence Scale
timeFrame: Baseline-Week 12
measure: Study Cigarettes Smoked Per Day
timeFrame: Baseline-Week 12
measure: IVR Review and Timeline Followback and E-liquid Accountability
timeFrame: Baseline-Week 12
measure: Number of Choices to Smoke in Preference Assessment Task
timeFrame: Week 00
measure: Purchase Task
timeFrame: Baseline, Week 12
measure: Predicted Behavior Questionnaire
timeFrame: Week 12
measure: IVR Review and Timeline Followback
timeFrame: Baseline-Week 12
measure: Drop-out Rate
timeFrame: Baseline-Week 12
measure: Urge to Use Questionnaire
timeFrame: Baseline-Week 12
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline, Weeks 04, 08, 12
measure: Breath Alcohol
timeFrame: Baseline - Week 12
measure: Urine Drug Screen
timeFrame: Baseline, Week 12
measure: Alcohol Use Questionnaire
timeFrame: Baseline-Week 12
measure: Drug Use Questionnaire
timeFrame: Baseline-Week 12
measure: Weight
timeFrame: Baseline-Week 12
measure: Urinary Anatabine Biomarker
timeFrame: Baseline -Week 12
measure: Total Nicotine Equivalents
timeFrame: Baseline - Week 12
measure: Environmental and Social Influences on Tobacco Use Questionnaire
timeFrame: Baseline-Week 12
measure: Context of Product Use Questionnaire
timeFrame: Baseline-Week 12
measure: Puff Topography
timeFrame: Weeks 01 and 10
measure: Vaping Utility Questionnaire
timeFrame: Baseline, Week 12
measure: Smoking and Vaping Expectancy Questionnaires
timeFrame: Baseline-Week 12
measure: Cigarette and Product Evaluation Scale
timeFrame: Baseline-Week 12
measure: Perceived Health Risk Questionnaire
timeFrame: Baseline-Week 12
measure: Penn State Smoking Dependence Questionnaire
timeFrame: Baseline-Week 12
measure: Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM)
timeFrame: Baseline-Week 12
measure: Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions
timeFrame: Baseline-Week 12
measure: Stages of Change
timeFrame: Baseline-Week 12
measure: Contemplation Ladder
timeFrame: Baseline-Week 12
measure: Quit Attempts
timeFrame: Baseline-Week 12
measure: Post-intervention Changes in Tobacco Use Behavior
timeFrame: 30 Day Follow up
measure: Qualitative Interview
timeFrame: 30 Day Follow up
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Biotech Place
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Wake Forest University Health Sciences
name: Eric Donny, PhD
role: PRINCIPAL_INVESTIGATOR
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