Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)

Not Applicable

Completed

• Conditions: Smoking; Tobacco Use

• Registration Number: NCT03453385
• Lead Sponsor: Medical University of South Carolina

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-03-05
• Study Start: 2018-05-24
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Results First Submitted: 2023-08-09
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Results First Posted: 2023-09-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
E-cig Use at End of Sampling Period	at week 4	percentage of participants reporting using an e-cigarette

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States