| Registry | NCT03453385, acronym CONNECT |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 638 (Actual) |
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| Sponsor | Medical University of South Carolina (Other); collaborators: National Cancer Institute (NCI) |
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| Conditions | Smoking, Tobacco Use |
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| Interventions | Electronic Cigarette (Behavioral) |
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| Dates | start 2018-05-24, primary completion 2022-09-08, completion 2022-09-08, first posted 2018-03-05, last updated 2023-09-11 |
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| Locations | 1 site in United States |
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-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.
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+Detailed description
Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Control | No intervention | | Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. |
| Sampling | Experimental | Behavioral: Electronic Cigarette | Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. |
- Electronic Cigarette (Behavioral): An e-cigarette and four weeks of e-liquid provided to participants.
+Outcome measures
Primary outcomes
- E-cig Use at End of Sampling Period [at week 4]: percentage of participants reporting using an e-cigarette
Secondary outcomes
- Conversion [Study enrollment through end of 6-month follow up]: Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own
- Smoking Cessation [at 6-month follow-up]: Point prevalence abstinence from conventional smoking
+Eligibility
Sex: All, ages: 21 Years to any, accepts healthy volunteers
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
+Posted results
Participant flow
| Milestone | Control | Sampling |
|---|
| Started | 211 | 427 |
| Completed | 211 | 427 |
| Not completed | 0 | 0 |
Outcome results
- E-cig Use at End of Sampling Period (Primary), Number, percentage of participants: Control 13; Sampling 72
- Conversion (Secondary), Number, percentage of participants: Control 20; Sampling 19
- Smoking Cessation (Secondary), Number, percentage of participants: Control 8; Sampling 14
Adverse events
Time frame: study weeks 1 through 24
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Control | 0/211 (0.0%) | 0/211 (0.0%) | 98/211 (46.4%) |
| Sampling | 0/427 (0.0%) | 1/427 (0.2%) | 177/427 (41.5%) |
Serious adverse events by term
| Term | Organ system | Control | Sampling |
|---|
| asthma-induced hospitalization | Respiratory, thoracic and mediastinal disorders | 0/211 | 1/427 |
Other adverse events by term
| Term | Organ system | Control | Sampling |
|---|
| cough | Respiratory, thoracic and mediastinal disorders | 43/211 | 73/427 |
| headache | Nervous system disorders | 17/211 | 52/427 |
| increased phlegm | Gastrointestinal disorders | 38/211 | 52/427 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Medical University of South Carolina | Charleston, South Carolina | United States | |
+Publications
- Results publication: Carpenter MJ, Wahlquist AE, Dahne J, Gray KM, Cummings KM, Warren G, Wagener TL, Goniewicz ML, Smith TT. Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial. EClinicalMedicine. 2023 Aug 15;63:102142. doi: 10.1016/j.eclinm.2023.102142. eCollection 2023 Sep. PMID 37753443
+Study documents
+Funding