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

Target enrollment

638 participants

Primary outcome timeframe

at week 4

Results posted on

2023-09-11

Participant Flow

Participant milestones

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

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=99 Participants	42.4 years STANDARD_DEVIATION 11.2 • n=107 Participants	42.2 years STANDARD_DEVIATION 11.55 • n=206 Participants
Sex: Female, Male Female	120 Participants n=99 Participants	222 Participants n=107 Participants	342 Participants n=206 Participants
Sex: Female, Male Male	91 Participants n=99 Participants	205 Participants n=107 Participants	296 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=99 Participants	63 Participants n=107 Participants	90 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	184 Participants n=99 Participants	364 Participants n=107 Participants	548 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized White	146 Participants n=99 Participants	291 Participants n=107 Participants	437 Participants n=206 Participants
Race/Ethnicity, Customized Black	32 Participants n=99 Participants	86 Participants n=107 Participants	118 Participants n=206 Participants
Race/Ethnicity, Customized Other	33 Participants n=99 Participants	50 Participants n=107 Participants	83 Participants n=206 Participants
Motivation to Quit Smoking (0-10 scale)	4.5 units on a scale STANDARD_DEVIATION 3.1 • n=99 Participants	4.3 units on a scale STANDARD_DEVIATION 3.3 • n=107 Participants	4.4 units on a scale STANDARD_DEVIATION 3.2 • n=206 Participants

PRIMARY outcome

Timeframe: at week 4

percentage of participants reporting using an e-cigarette

Outcome measures

Outcome measures
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.
E-cig Use at End of Sampling Period	13 percentage of participants	72 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

Outcome measures
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.
Conversion	20 percentage of participants	19 percentage of participants

SECONDARY outcome

Timeframe: at 6-month follow-up

Point prevalence abstinence from conventional smoking

Outcome measures

Outcome measures
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.
Smoking Cessation	8 percentage of participants	14 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

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

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place