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

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use
• Intervention / Treatment: Behavioral: Electronic Cigarette

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: Interventional
• Enrollment (Actual): 638
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-cig Use at End of Sampling Period	percentage of participants reporting using an e-cigarette	at week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion	Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own	Study enrollment through end of 6-month follow up
Smoking Cessation	Point prevalence abstinence from conventional smoking	at 6-month follow-up

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Smoking; Tobacco; Nicotine; Electronic Cigarette
• Other Study ID Numbers: 493; 1R01CA210625-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No