Trial Outcomes & Findings for Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT) (NCT NCT03453385)

NCT ID: NCT03453385

Last Updated: 2023-09-11

Results Overview

percentage of participants reporting using an e-cigarette

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 638 participants
• Primary outcome timeframe: at week 4
• Results posted on: 2023-09-11

Participant Flow

Participant milestones

Measure	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.	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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.
Overall Study STARTED	211	427
Overall Study COMPLETED	211	427
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control n=211 Participants 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 n=427 Participants 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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.	Total n=638 Participants Total of all reporting groups
Age, Continuous	42.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	42.4 years STANDARD_DEVIATION 11.2 • n=7 Participants	42.2 years STANDARD_DEVIATION 11.55 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	222 Participants n=7 Participants	342 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	205 Participants n=7 Participants	296 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	63 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	184 Participants n=5 Participants	364 Participants n=7 Participants	548 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	146 Participants n=5 Participants	291 Participants n=7 Participants	437 Participants n=5 Participants
Race/Ethnicity, Customized Black	32 Participants n=5 Participants	86 Participants n=7 Participants	118 Participants n=5 Participants
Race/Ethnicity, Customized Other	33 Participants n=5 Participants	50 Participants n=7 Participants	83 Participants n=5 Participants
Motivation to Quit Smoking (0-10 scale)	4.5 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	4.3 units on a scale STANDARD_DEVIATION 3.3 • n=7 Participants	4.4 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants

PRIMARY outcome

Timeframe: at week 4

percentage of participants reporting using an e-cigarette

Outcome measures

Measure	Sampling n=427 Participants 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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.	Control n=211 Participants 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.
E-cig Use at End of Sampling Period	72 percentage of participants	13 percentage of participants

SECONDARY outcome

Timeframe: Study enrollment through end of 6-month follow up

Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own

Outcome measures

Measure	Sampling n=427 Participants 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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.	Control n=211 Participants 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.
Conversion	19 percentage of participants	20 percentage of participants

SECONDARY outcome

Timeframe: at 6-month follow-up

Point prevalence abstinence from conventional smoking

Outcome measures

Measure	Sampling n=427 Participants 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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.	Control n=211 Participants 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.
Smoking Cessation	14 percentage of participants	8 percentage of participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 98 other events

Deaths: 0 deaths

Sampling

Serious events: 1 serious events

Other events: 177 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=211 participants at risk 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 n=427 participants at risk 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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.
Respiratory, thoracic and mediastinal disorders asthma-induced hospitalization	0.00% 0/211 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.	0.23% 1/427 • Number of events 1 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.

Other adverse events

Measure	Control n=211 participants at risk 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 n=427 participants at risk 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. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.
Respiratory, thoracic and mediastinal disorders cough	20.4% 43/211 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.	17.1% 73/427 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.
Nervous system disorders headache	8.1% 17/211 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.	12.2% 52/427 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.
Gastrointestinal disorders increased phlegm	18.0% 38/211 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.	12.2% 52/427 • study weeks 1 through 24 AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.

Additional Information

Dr. Matthew Carpenter

Medical University of South Carolina (MUSC)

Phone: 843-876-2436

Email: carpente@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place