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CompletedNCT03511001Updated Oct 12, 2021Results posted

Effects Among Smokers Who Use and Do Not Use E-Cigarettes

An interventional study of E-Cigarette Vs. Smoking as Usual in Toxicant Exposure, sponsored by California State University, San Marcos. Completed at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by California State University, San Marcos · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.

02

Conditions studied

  • Toxicant Exposure
03

In context

Lead sponsor

California State University, San Marcos is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 21 years of age
  • Smoked cigarettes on > 25 of past 30 days
  • Smoked > 5 cigarettes per day on days smoked
  • Smoked cigarettes > 6 months
  • Carbon monoxide > 5 PPM at baseline
  • Hispanic/Latino or African American/Black
  • Fluent in English or Spanish
  • Willing to switch from smoking cigarettes to ECs for 6 weeks
  • Regular access to telephone
  • Transportation to attend appointments (KC Only)

Exclusion criteria

Exclusion Criteria:

  • Primary use of other tobacco products or equal use of cigarettes and other tobacco products
  • Electronic cigarette use on > 4 of the past 30 days
  • Currently in a smoking cessation program or another clinical trial
  • Use of nicotine replacement therapy or medication which aids smoking cessation in the past 30 days
  • Hospitalization for a psychiatric issue in the past 30 days
  • Heart-related event in the past 30 days. Examples include heart attack, stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular disease
  • Uncontrolled blood pressure at baseline
  • Planning to move out of San Diego or Kansas City in the next 6 weeks
  • Another person in the household enrolled in the study
  • Women: pregnant, breastfeeding, or planning to become pregnant in the next six months
  • Unstable mental status or health status
05

Study design

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

Study arms

  • Experimental
    E-Cigarette

    6 weeks of JUUL electronic cigarettes

    Other: E-Cigarette Vs. Smoking as Usual

  • Active comparator
    Assessment Only

    6 weeks of smoking as usual

    Other: E-Cigarette Vs. Smoking as Usual

Interventions

  • OtherE-Cigarette Vs. Smoking as Usual

    6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual

06

What researchers measure

Primary outcomes

  1. Toxicant Exposure

    Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: 6 weeks

Secondary outcomes

  1. Carbon Monoxide

    Carbon monoxide at week 6. Breath test (PPM)

    Time frame: 6 weeks

  2. Respiratory Symptoms

    Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes

    Time frame: 6 weeks

  3. Lung Function

    FEF 25%-75%, L/s at week 6 measured by spirometer

    Time frame: 6 weeks

  4. Systolic Blood Pressure

    Systolic blood pressure at week 6

    Time frame: 6 weeks

  5. Diastolic Blood Pressure

    Diastolic blood pressure at week 6

    Time frame: 6 weeks

  6. Tobacco Dependence

    Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes

    Time frame: 6 weeks

  7. Self-efficacy to Resist Smoking

    Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome

    Time frame: 6 weeks

07

Results

Posted Sep 5, 2021

Participant flow

Participant flow — Overall Study
MilestoneE-CigaretteAssessment Only
Started12661
Completers analyzed11461
Completed11554
Not completed117

Outcome measures

PrimaryToxicant Exposure

Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame:
6 weeks
Reported as:
Median · pg/ml
Toxicant Exposure
pg/mlE-CigaretteAssessment Only
Toxicant Exposure40 (12 to 101)97 (39 to 222)
SecondaryCarbon Monoxide

Carbon monoxide at week 6. Breath test (PPM)

Time frame:
6 weeks
Reported as:
Median · ppm
Carbon Monoxide
ppmE-CigaretteAssessment Only
Carbon Monoxide7 (3 to 14)16 (9 to 25)
SecondaryRespiratory Symptoms

Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes

Time frame:
6 weeks
Reported as:
Median · score on a scale
Respiratory Symptoms
score on a scaleE-CigaretteAssessment Only
Respiratory Symptoms7 (3 to 12)9 (4 to 16)
SecondaryLung Function

FEF 25%-75%, L/s at week 6 measured by spirometer

Time frame:
6 weeks
Reported as:
Median · L/sec
Lung Function
L/secE-CigaretteAssessment Only
Lung Function2.8 (1.8 to 4.1)2.7 (2.1 to 4.1)
SecondarySystolic Blood Pressure

Systolic blood pressure at week 6

Time frame:
6 weeks
Reported as:
Median · mmHg
Systolic Blood Pressure
mmHgE-CigaretteAssessment Only
Systolic Blood Pressure128 (117 to 142)133 (122 to 143)
SecondaryDiastolic Blood Pressure

Diastolic blood pressure at week 6

Time frame:
6 weeks
Reported as:
Median · mmHg
Diastolic Blood Pressure
mmHgE-CigaretteAssessment Only
Diastolic Blood Pressure83 (74 to 89)83 (75 to 89)
SecondaryTobacco Dependence

Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes

Time frame:
6 weeks
Reported as:
Median · score on a scale
Tobacco Dependence
score on a scaleE-CigaretteAssessment Only
Tobacco Dependence18.5 (15.0 to 36.3)41.0 (33.8 to 57.5)
SecondarySelf-efficacy to Resist Smoking

Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome

Time frame:
6 weeks
Reported as:
Median · score on a scale
Self-efficacy to Resist Smoking
score on a scaleE-CigaretteAssessment Only
Self-efficacy to Resist Smoking43.0 (26.5 to 56.0)20.0 (12.5 to 30.5)

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
E-Cigarette0/114 (0%)0/114 (0%)46/114 (40.4%)
Assessment Only0/54 (0%)0/54 (0%)22/54 (40.7%)
Most frequent other events
Most frequent other events
EventE-CigaretteAssessment Only
Dry Mouth/ThroatRespiratory, thoracic and mediastinal disorders46/11422/54
DizzinessNervous system disorders19/11414/54
Rapid Heart RateCardiac disorders18/11412/54
Irritated Mouth/ThroatRespiratory, thoracic and mediastinal disorders24/11411/54
Nauseau and/or VomitingGastrointestinal disorders19/11411/54

Baseline characteristics

One post-randomization exclusion from analyses due to not meeting race/ethnicity inclusion criteria

Age, Continuous
Age, Continuous(years)E-CigaretteAssessment OnlyTotal
Mean44.1 ± 12.741.7 ± 11.943.3 ± 12.5
Sex: Female, Male
Sex: Female, Male(Participants)E-CigaretteAssessment OnlyTotal
Female492675
Male7635111
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)E-CigaretteAssessment OnlyTotal
Hispanic or Latino633194
Not Hispanic or Latino623092
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)E-CigaretteAssessment OnlyTotal
American Indian or Alaska Native8412
Asian112
Native Hawaiian or Other Pacific Islander202
Black or African American663096
White362460
More than one race9211
Unknown or Not Reported303
Region of Enrollment
Region of Enrollment(participants)E-CigaretteAssessment OnlyTotal
United States12561186
High school education or less
High school education or less(Participants)E-CigaretteAssessment OnlyTotal
Count of participants6834102
200% federal poverty level or lower
200% federal poverty level or lower(Participants)E-CigaretteAssessment OnlyTotal
Count of participants9345138
Never married
Never married(Participants)E-CigaretteAssessment OnlyTotal
Count of participants593190

18 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • California State University San Marcos
    San Marcos, California 92096, United States
  • Swope Health Central
    Kansas City, Missouri 64130, United States
09

References and documents

Publications

  • Nollen NL, Leavens ELS, Ahluwalia JS, Rice M, Mayo MS, Pulvers K. Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial. Tob Control. 2023 Nov;32(6):786-789. doi: 10.1136/tobaccocontrol-2021-057180. Epub 2022 Mar 29. PubMed 35351805 ↗
  • Pulvers K, Rice M, Ahluwalia JS, Arnold MJ, Marez C, Nollen NL. "It is the One Thing that has Worked": facilitators and barriers to switching to nicotine salt pod system e-cigarettes among African American and Latinx people who smoke: a content analysis. Harm Reduct J. 2021 Sep 16;18(1):98. doi: 10.1186/s12954-021-00543-y. PubMed 34530834 ↗
  • Arnold MJ, Nollen NL, Mayo MS, Ahluwalia JS, Leavens EL, Zhang G, Rice M, Pulvers K. Harm Reduction Associated with Dual Use of Cigarettes and e-Cigarettes in Black and Latino Smokers: Secondary Analyses from a Randomized Controlled e-Cigarette Switching Trial. Nicotine Tob Res. 2021 Oct 7;23(11):1972-1976. doi: 10.1093/ntr/ntab069. PubMed 33837422 ↗
  • Pulvers K, Nollen NL, Rice M, Schmid CH, Qu K, Benowitz NL, Ahluwalia JS. Effect of Pod e-Cigarettes vs Cigarettes on Carcinogen Exposure Among African American and Latinx Smokers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2026324. doi: 10.1001/jamanetworkopen.2020.26324. PubMed 33206193 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03511001
Lead sponsor
California State University, San Marcos
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Sponsor
First posted
Apr 27, 2018
Start date
May 17, 2018
Primary completion
May 10, 2019
Completion
Sep 26, 2019
Results posted
Sep 5, 2021
Last update
Oct 12, 2021

Study contacts

Kim Pulvers, PhD, MPH
principal investigator · Associate Professor

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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