ClinicalTrials.gg
CompletedNCT03453385CONNECTUpdated Sep 11, 2023Results posted

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

An interventional study of Electronic Cigarette in Smoking and Tobacco Use, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
638
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in Smoking by Medical University of South Carolina — 8 open to participants now, 8 under way, none of them phase 3. Smoking · Medical University of South Carolina.

Enrollment
5th of 29
638 · median 99
Started
2018
with 4 others
No phase
23 of 30
7 open now
Registered
14th of 30
by date

Among the 30 studies in Smoking by Medical University of South Carolina, this one is the 5th largest by enrollment of the 29 interventional ones that give a count, is one of 5 that started in 2018, is one of 23 with no phase, and was the 14th registered.

Smoking

1,510 studies on the registry are indexed under Smoking; 193 are open to participants now.

Browse Smoking studies →

Open to participants now

8 of the 30 studies in Smoking by Medical University of South Carolina are open now, in 1 country. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 140 Smoking studies recruiting now, 74 (53%) set no upper age limit and 48 (34%) stop at 75 or younger; 3 take children under 18; 65 take healthy volunteers.

This study: 21 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Smoking by Medical University of South Carolina, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Smoking
  • Tobacco Use

Keywords

  • Smoking
  • Nicotine
  • Tobacco
  • Electronic Cigarette
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
638 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralElectronic Cigarette

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

06

What researchers measure

Primary outcomes

  1. E-cig Use at End of Sampling Period

    percentage of participants reporting using an e-cigarette

    Time frame: at week 4

Secondary outcomes

  1. Conversion

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

    Time frame: Study enrollment through end of 6-month follow up

  2. Smoking Cessation

    Point prevalence abstinence from conventional smoking

    Time frame: at 6-month follow-up

07

Results

Posted Sep 11, 2023

Participant flow

Participant flow — Overall Study
MilestoneControlSampling
Started211427
Completed211427
Not completed00

Outcome measures

PrimaryE-cig Use at End of Sampling Period

percentage of participants reporting using an e-cigarette

Time frame:
at week 4
Reported as:
Number · percentage of participants
E-cig Use at End of Sampling Period
percentage of participantsControlSampling
E-cig Use at End of Sampling Period1372
SecondaryConversion

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

Time frame:
Study enrollment through end of 6-month follow up
Reported as:
Number · percentage of participants
Conversion
percentage of participantsControlSampling
Conversion2019
SecondarySmoking Cessation

Point prevalence abstinence from conventional smoking

Time frame:
at 6-month follow-up
Reported as:
Number · percentage of participants
Smoking Cessation
percentage of participantsControlSampling
Smoking Cessation814

Adverse events

Collected over study weeks 1 through 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/211 (0%)0/211 (0%)98/211 (46.4%)
Sampling0/427 (0%)1/427 (0.2%)177/427 (41.5%)
Most frequent serious events
Most frequent serious events
EventControlSampling
asthma-induced hospitalizationRespiratory, thoracic and mediastinal disorders0/2111/427
Most frequent other events
Most frequent other events
EventControlSampling
coughRespiratory, thoracic and mediastinal disorders43/21173/427
increased phlegmGastrointestinal disorders38/21152/427
headacheNervous system disorders17/21152/427

Baseline characteristics

Age, Continuous
Age, Continuous(years)ControlSamplingTotal
Mean42.0 ± 11.942.4 ± 11.242.2 ± 11.55
Sex: Female, Male
Sex: Female, Male(Participants)ControlSamplingTotal
Female120222342
Male91205296
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ControlSamplingTotal
Hispanic or Latino276390
Not Hispanic or Latino184364548
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ControlSamplingTotal
White146291437
Black3286118
Other335083
Motivation to Quit Smoking (0-10 scale)
Motivation to Quit Smoking (0-10 scale)(units on a scale)ControlSamplingTotal
Mean4.5 ± 3.14.3 ± 3.34.4 ± 3.2
08

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Sep 2022, 51 months.

Results were first posted in Sep 2023, 1 year after primary completion.

Of 402 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 51 months is above that.

Counting every sponsor, half of 457 studies reached it within 23 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2018
First posted
Mar 5, 2018
StartActual
May 24, 2018
Primary completionActual
Sep 8, 2022
CompletionActual
Sep 8, 2022
Results first posted
Sep 11, 2023
Last update
Sep 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03453385
Responsible party
Matthew Carpenter (Professor, Medical University of South Carolina) — Principal investigator
First posted
Mar 5, 2018
Start date
May 24, 2018
Primary completion
Sep 8, 2022
Completion
Sep 8, 2022
Results posted
Sep 11, 2023
Last update
Sep 11, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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