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Completed

NCT Number: NCT03185546

Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

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.

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Key information

Conditions

Smoking Behavior Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Biotech Place, Winston-Salem, North Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC Spectrum Cigarette

Other

Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

VLNC Spectrum Cigarette

Other

Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

Moderate nicotine level e-liquid

Other

Participants are provided with moderate nicotine level e-liquid for 13 weeks

Low nicotine level e-liquid

Other

Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

Tobacco Flavors

Other

Participants can choose e-liquid flavors from a selection of tobacco flavors

Tobacco and non-tobacco e-liquid flavors

Other

Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Primary outcomes

  1. Total Cigarettes Smoked Per Day

    Time frame: Week 10 through Week 12

    The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).

Secondary outcomes

  1. Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)

    Time frame: Baseline - Week 12

    Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm).

  2. Number of Subjects With Smoke Free Days

    Time frame: Baseline-Week 12

    Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study.

Other outcomes

  1. Minnesota Nicotine Withdrawal Scale

    Time frame: Baseline-Week 12

    Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms.

  2. Number of Days Using Assigned Vaping Device

    Time frame: Baseline-Week 12

    collected through Interactive Voice Response (IVR) Review

  3. Cigarette Evaluation Scale

    Time frame: Baseline-Week 12

    Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations.

  4. Mercapturic Acids

    Time frame: Baseline-Week 12

    Measure of toxicant exposure

  5. Fagerstrom Nicotine Dependence Scale

    Time frame: Baseline-Week 12

    Dependence Measure

  6. Study Cigarettes Smoked Per Day

    Time frame: Baseline-Week 12

    Study cigarettes smoked per day

  7. IVR Review and Timeline Followback and E-liquid Accountability

    Time frame: Baseline-Week 12

    Measure of vaping device use

  8. Number of Choices to Smoke in Preference Assessment Task

    Time frame: Week 00

    Measure of relative reinforcement

  9. Purchase Task

    Time frame: Baseline, Week 12

    Measure of relative reinforcement and substitution

  10. Predicted Behavior Questionnaire

    Time frame: Week 12

    Measure of hypothetical cigarette and vaping device use

  11. IVR Review and Timeline Followback

    Time frame: Baseline-Week 12

    Measure of compliance

  12. Drop-out Rate

    Time frame: Baseline-Week 12

    Drop-out rate

  13. Urge to Use Questionnaire

    Time frame: Baseline-Week 12

    Measure of discomfort and dysfunction

  14. Center for Epidemiologic Studies Depression Scale

    Time frame: Baseline, Weeks 04, 08, 12

    Measure of discomfort and dysfunction

  15. Breath Alcohol

    Time frame: Baseline - Week 12

    Alcohol use

  16. Urine Drug Screen

    Time frame: Baseline, Week 12

    Drug use

  17. Alcohol Use Questionnaire

    Time frame: Baseline-Week 12

    Alcohol use

  18. Drug Use Questionnaire

    Time frame: Baseline-Week 12

    Drug use

  19. Weight

    Time frame: Baseline-Week 12

    Weight

  20. Urinary Anatabine Biomarker

    Time frame: Baseline -Week 12

    Measure of cigarette exposure and compliance

  21. Total Nicotine Equivalents

    Time frame: Baseline - Week 12

    Measure of nicotine exposure

  22. Environmental and Social Influences on Tobacco Use Questionnaire

    Time frame: Baseline-Week 12

    Measure of smoking and vaping context

  23. Context of Product Use Questionnaire

    Time frame: Baseline-Week 12

    Measure of smoking and vaping context

  24. Puff Topography

    Time frame: Weeks 01 and 10

    Measure of smoking and vaping topography

  25. Vaping Utility Questionnaire

    Time frame: Baseline, Week 12

    Measure of product expectancy

  26. Smoking and Vaping Expectancy Questionnaires

    Time frame: Baseline-Week 12

    Measure of product expectancy

  27. Cigarette and Product Evaluation Scale

    Time frame: Baseline-Week 12

    Measure of product characteristics

  28. Perceived Health Risk Questionnaire

    Time frame: Baseline-Week 12

    Measure of perceived personal health risk

  29. Penn State Smoking Dependence Questionnaire

    Time frame: Baseline-Week 12

    Dependence Measure (smoking and vaping)

  30. Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM)

    Time frame: Baseline-Week 12

    Dependence Measure

  31. Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions

    Time frame: Baseline-Week 12

    Dependence Measure (smoking and vaping)

  32. Stages of Change

    Time frame: Baseline-Week 12

    Measure of intention to quit

  33. Contemplation Ladder

    Time frame: Baseline-Week 12

    Measure of intention to quit

  34. Quit Attempts

    Time frame: Baseline-Week 12

    Measure of intention to quit

  35. Post-intervention Changes in Tobacco Use Behavior

    Time frame: 30 Day Follow up

    Measure of 30-day tobacco use post-intervention of study products

  36. Qualitative Interview

    Time frame: 30 Day Follow up

    Themes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Pennsylvania

Registry information

Official study title

Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2017
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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