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

Smoking Clinical Trial

— CONNECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453385
• Other study ID #: 493
• Secondary ID: 1R01CA210625-01A
• Status: Completed
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: September 8, 2022

Study information

• Verified date: September 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Tobacco Use

Intervention

Behavioral:
• Electronic Cigarette
An e-cigarette and four weeks of e-liquid provided to participants.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E-cig Use at End of Sampling Period	percentage of participants reporting using an e-cigarette	at week 4
Secondary	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
Secondary	Smoking Cessation	Point prevalence abstinence from conventional smoking	at 6-month follow-up