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

NCT03453385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 638

Last updated 2023-09-11

Study results available
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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.

Conditions

  • Smoking
  • Tobacco Use

Interventions

BEHAVIORAL

Electronic Cigarette

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2022-09-08
Completion
2022-09-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03453385 on ClinicalTrials.gov