Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453385
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Matthew Carpenter, 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.

Condition or disease Intervention/treatment Phase
Smoking Tobacco Use Behavioral: Electronic Cigarette Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: Sampling
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.
Behavioral: Electronic Cigarette
An e-cigarette and four weeks of e-liquid provided to participants.




Primary Outcome Measures :
  1. Uptake [ Time Frame: Study Enrollment through end of 4-week intervention ]
    mean days of use over 4-week sampling period


Secondary Outcome Measures :
  1. Conversion [ Time Frame: Study enrollment through end of 6-month follow up ]
    Percentage of participants who purchase an e-cigarette

  2. Smoking Cessation [ Time Frame: 6-month follow-up ]
    Point prevalence abstinence from conventional smoking



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453385


Contacts
Layout table for location contacts
Contact: Amy Boatright 8438762440 boatrigh@musc.edu

Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amy Boatright    800-375-0516      
Sponsors and Collaborators
Medical University of South Carolina
National Cancer Institute (NCI)
Layout table for additonal information
Responsible Party: Matthew Carpenter, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03453385    
Other Study ID Numbers: 493
1R01CA210625-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Carpenter, Medical University of South Carolina:
Smoking
Nicotine
Tobacco
Electronic Cigarette