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

NCT03453385 | Completed Results DMC

• 2 other identifiers: 4931R01CA210625-01A1
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Tobacco Use

Keywords

Smoking; Nicotine; Tobacco; Electronic Cigarette

Outcome Measures

Primary Outcomes (1)

• E-cig Use at End of Sampling Period

  percentage of participants reporting using an e-cigarette

  at week 4

Secondary Outcomes (2)

• Conversion

  Study enrollment through end of 6-month follow up

• Smoking Cessation

  at 6-month follow-up

Study Arms (2)

Control

NO INTERVENTION

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.

Sampling

EXPERIMENTAL

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

Interventions

Electronic Cigarette BEHAVIORAL

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

Sampling

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Carpenter MJ, Wahlquist AE, Dahne J, Gray KM, Cummings KM, Warren G, Wagener TL, Goniewicz ML, Smith TT. Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial. EClinicalMedicine. 2023 Aug 15;63:102142. doi: 10.1016/j.eclinm.2023.102142. eCollection 2023 Sep.

  PMID: 37753443 DERIVED

MeSH Terms

Conditions

Smoking; Tobacco Use; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Matthew Carpenter
• Organization: Medical University of South Carolina (MUSC)

carpente@musc.edu

843-876-2436

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: May 24, 2018
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: September 11, 2023
• Results First Posted: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)