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

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE May 24, 2018
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Uptake [ Time Frame: Study Enrollment through end of 4-week intervention ]
mean days of use over 4-week sampling period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Conversion [ Time Frame: Study enrollment through end of 6-month follow up ]
    Percentage of participants who purchase an e-cigarette
  • Smoking Cessation [ Time Frame: 6-month follow-up ]
    Point prevalence abstinence from conventional smoking
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • Conversation [ Time Frame: Study enrollment through end of 6-month follow up ]
    Percentage of participants who purchase an e-cigarette
  • Smoking Cessation [ Time Frame: 6-month follow-up ]
    Point prevalence abstinence from conventional smoking
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
Official Title  ICMJE Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Smoking
  • Tobacco Use
Intervention  ICMJE Behavioral: Electronic Cigarette
An e-cigarette and four weeks of e-liquid provided to participants.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Electronic Cigarette
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2018)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Amy Boatright 8438762440 boatrigh@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03453385
Other Study ID Numbers  ICMJE 493
1R01CA210625-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Carpenter, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP