Toxicant ExposureNCT03511001
Effects Among Smokers Who Use and Do Not Use E-Cigarettes
A study testing E-Cigarette Vs. Smoking as Usual in people with Toxicant Exposure, run by California State University, San Marcos at 2 sites in United States.
Trial summary
This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Toxicant Exposure
- What is being tested?
- E-Cigarette Vs. Smoking as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 May 2018to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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
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- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Swope Health Central
Kansas City, Missouri, 64130
California State University San Marcos
San Marcos, California, 92096
About this study
This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.
- Conditions
- Toxicant Exposure
- Being tested
- E-Cigarette Vs. Smoking as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Cigarette Vs. Smoking as UsualOther
6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarette | Experimental | 6 weeks of JUUL electronic cigarettes Receives: Other: E-Cigarette Vs. Smoking as Usual |
| Assessment Only | Active comparator | 6 weeks of smoking as usual Receives: Other: E-Cigarette Vs. Smoking as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicant Exposure
Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Measured: 6 weeks
Secondary outcomes (7)
Carbon Monoxide
Carbon monoxide at week 6. Breath test (PPM)
Measured: 6 weeks
Respiratory Symptoms
Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes
Measured: 6 weeks
Lung Function
FEF 25%-75%, L/s at week 6 measured by spirometer
Measured: 6 weeks
Systolic Blood Pressure
Systolic blood pressure at week 6
Measured: 6 weeks
Diastolic Blood Pressure
Diastolic blood pressure at week 6
Measured: 6 weeks
Tobacco Dependence
Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start17 May 2018
- Primary completion10 May 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Toxicant ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, San Marcos
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Kim Pulvers, PhD, MPH, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511001
- Sponsor's protocol ID
- 1119341-85085
- Other IDs
- 1SC3GM122628
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2018
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35351805Pulvers 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 34530834Arnold 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 33837422Pulvers 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 at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Among Smokers Who Use and Do Not Use E-Cigarettes
- ClinicalTrials.gov ID
- NCT03511001
- Acronym / sponsor ID
- 1119341-85085
- Conditions
- Toxicant Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- California State University, San MarcosUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette | Experimental | Other: E-Cigarette Vs. Smoking as Usual6 weeks of JUUL electronic cigarettes |
| Assessment Only | Active comparator | Other: E-Cigarette Vs. Smoking as Usual6 weeks of smoking as usual |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- > 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-Cigarette Vs. Smoking as Usual6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual | Other | Assessment Only, E-Cigarette |
Primary outcome
Toxicant Exposure
Time frame: 6 weeks
Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
7 secondary outcomes
Carbon Monoxide
Time frame: 6 weeks
Respiratory Symptoms
Time frame: 6 weeks
Lung Function
Time frame: 6 weeks
Systolic Blood Pressure
Time frame: 6 weeks
Diastolic Blood Pressure
Time frame: 6 weeks
Tobacco Dependence
Time frame: 6 weeks
Self-efficacy to Resist Smoking
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35351805Nollen 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.
- Derived from this study: PubMed 34530834Pulvers 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.
- Derived from this study: PubMed 33837422Arnold 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.
- Derived from this study: PubMed 33206193Pulvers 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.
- Individual participant dataSharing planned: Undecided
Related trials for Toxicant Exposure
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
RecruitingObservational study
Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)
Cigarette Smoking-Related Carcinoma, E-Cig Use
Recruiting
Cigarette Filter Study
Smoking ( Cigarette)
Not yet recruitingPhase 2
Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
RecruitingPhase 1/2
Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)
Toxicant Exposure, Firefighter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Pulvers, PhD, MPH principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Cigarette Vs. Smoking as Usual in people with Toxicant Exposure, run by California State University, San Marcos at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicant Exposure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511001, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.