Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/2/2018 |
| Start Date: | May 24, 2018 |
| End Date: | July 1, 2022 |
| Contact: | Amy Boatright |
| Email: | boatrigh@musc.edu |
| Phone: | 8438762440 |
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.
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.
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 800-375-0516
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