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N/A N=64 Randomized Single-blind Health Services Research

Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)

Tobacco Use

Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Cigarettes Purchased — 154.7; 119.2 average number of cigarettes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Normal Nicotine Content Vape with all flavor e-liquids (Other); Normal nicotine content vape with tobacco e-liquids (Other); Low nicotine content vape with all flavor e-liquids (Other); Low nicotine content vape with tobacco e-liquids (Other)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Cigarettes Purchased
154.7; 119.2
SECONDARY
Number of E-liquid Milliliters Purchased
36.7; 35.0
SECONDARY
Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections
41.8; 61.9
SECONDARY
Lung Cancer Perceived Risk Scores for VLNC Cigarettes
5.4; 4.2
SECONDARY
Product Evaluation Scale Scores
29.1; 29.1
SECONDARY
Minnesota Nicotine Withdrawal Scale Scores
5.3; 4.9
SECONDARY
Questionnaire on Smoking Urges Score
36.1; 32.4
SECONDARY
Tobacco Product Interest Scores
87.2; 88.4; 27.1; 32.2; 38.3; 33.2
SECONDARY
Tobacco Policy Questionnaire Scores
15; 11; 7; 11; 7; 10

Summary

This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.

Eligibility Criteria

Inclusion Criteria

  • 21+ years of age
  • Self-report smoking at least 5 cigarettes per day for the past year
  • Breathe carbon monoxide (CO) level > 8 ppm or positive urine NicCheck
  • Willingness to use other tobacco products during the study
  • Speak, comprehend, and read English sufficiently to complete study procedures
  • Have home access to a computer, smart phone, or tablet with a web camera and internet access
  • Tried a vaping device at least once in their lifetime

Exclusion Criteria

  • Currently seeking treatment to quit smoking
  • Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
  • Body temperature > 100.4 F
  • Cold, flu or COVID-19 symptoms including fever, cough, and runny nose in the past 30 days
  • Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
  • CO reading > 80 ppm
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05320887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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