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OpenTrials
Completed

NCT Number: NCT03453385

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

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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Key information

Conditions

Smoking Behavior Tobacco Use Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Cigarette

Behavioral

An e-cigarette and four weeks of e-liquid provided to participants.

Primary outcomes

  1. E-cig Use at End of Sampling Period

    Time frame: at week 4

    percentage of participants reporting using an e-cigarette

Secondary outcomes

  1. Conversion

    Time frame: Study enrollment through end of 6-month follow up

    Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own

  2. Smoking Cessation

    Time frame: at 6-month follow-up

    Point prevalence abstinence from conventional smoking

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: CONNECT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2018
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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