N/A
N=638
Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
Smoking · Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT03453385 ↗Enrolled (actual)
638
Serious AEs
0.2%
Results posted
Sep 2023
Primary outcome: Primary: E-cig Use at End of Sampling Period — 13; 72 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electronic Cigarette (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY E-cig Use at End of Sampling Period |
13; 72 | — |
| SECONDARY Conversion |
20; 19 | — |
| SECONDARY Smoking Cessation |
8; 14 | — |
Summary
The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.
Eligibility Criteria
Inclusion Criteria
- age 21+,
- current smoker
- regular use of email OR capacity to receive SMS text and internet access
- additional smoking and health criteria determined at screening
Data sourced from ClinicalTrials.gov (NCT03453385). 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.