BiomarkersNCT03084315
Changes in Biomarkers Associated With Use of Electronic Cigarettes
A study testing E-Cig Zero Nicotine and E-Cig 24mg Nicotine in people with Biomarkers, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomarkers
- What is being tested?
- E-Cig Zero Nicotine and E-Cig 24mg Nicotine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2016to 8 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identify as African American or Black;
- age 18 years or older;
- smoke at least five cigarettes daily for the past year;
- not interested in quitting smoking in the next 6 months;
- Willing to use e-cigarettes;
- Good physical health (no unstable medical or mental health condition);
- no contraindications for e-cigarette use.
Who cannot join
- Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes;
- participation in a smoking cessation program in the past 30 days;
- pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
Read the detailed description
This study compares patterns of e-cigarette use and the exposure to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in African American smokers, randomized to ad lib e-cigarettes containing nicotine vs. no nicotine. We hypothesized that nicotine e-cigarettes would be used more than no-nicotine e-cigarettes, and that this would be associated with reduced use of combustible cigarettes. We hypothesized that nicotine e-cigarettes would result in more substitution for combusted cigarettes than no-nicotine e-cigarettes and result in lower levels of exposure to the tobacco-specific carcinogen NNAL. These results would be relevant for developing exposure reduction strategies for adult African American smokers.
- Conditions
- Biomarkers
- Being tested
- E-Cig Zero Nicotine, E-Cig 24mg Nicotine
- Keywords
- smoking, electronic cigarettes, nicotine
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Cig Zero NicotineDevice
E-Cig Zero Nicotine
E-Cig 24mg NicotineDevice
E-Cig 24mg Nicotine
| Study group | Role | What they receive |
|---|---|---|
| E-Cig Zero Nicotine | Sham comparator | E-Cigarette with no nicotine added Receives: Device: E-Cig Zero Nicotine |
| E-Cig 24mg Nicotine | Active comparator | E-cigarette with 24mg of nicotine added Receives: Device: E-Cig 24mg Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biomarker Concentrations: Nicotine Equivalents
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Measured: Baseline, Week 6
Change in Biomarker Concentrations: NNAL
Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start15 Nov 2016
- Primary completion8 Mar 2019
- Study completion8 Mar 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 (1)Papers the sponsor has linked to this study.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blocked randomization, block size unknown to staff or investigators
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Joseph, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084315
- Sponsor's protocol ID
- 2015NTLS139
- Status last verified
- Aug 2021
- First submitted
- 13 Mar 2017
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Okuyemi KS, Ojo-Fati O, Aremu TO, Friedrichsen SC, Grude L, Oyenuga M, Shyne M, Murphy SE, Hatsukami D, Joseph AM. A Randomized Trial of Nicotine versus No-nicotine E-cigarettes Among African American Smokers: Changes in Smoking and Tobacco Biomarkers. Nicotine Tob Res. 2022 Mar 1;24(4):555-563. doi: 10.1093/ntr/ntab212.
PubMed 34669956
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
- ClinicalTrials.gov ID
- NCT03084315
- Acronym / sponsor ID
- 2015NTLS139
- Conditions
- Biomarkers
- Keywords
- smoking, electronic cigarettes, nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 20 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
Detailed description
This study compares patterns of e-cigarette use and the exposure to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in African American smokers, randomized to ad lib e-cigarettes containing nicotine vs. no nicotine. We hypothesized that nicotine e-cigarettes would be used more than no-nicotine e-cigarettes, and that this would be associated with reduced use of combustible cigarettes. We hypothesized that nicotine e-cigarettes would result in more substitution for combusted cigarettes than no-nicotine e-cigarettes and result in lower levels of exposure to the tobacco-specific carcinogen NNAL. These results would be relevant for developing exposure reduction strategies for adult African American smokers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blocked randomization, block size unknown to staff or investigators
| Arm | Type | Receives |
|---|---|---|
| E-Cig Zero Nicotine | Sham comparator | Device: E-Cig Zero NicotineE-Cigarette with no nicotine added |
| E-Cig 24mg Nicotine | Active comparator | Device: E-Cig 24mg NicotineE-cigarette with 24mg of nicotine added |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identify as African American or Black;
- age 18 years or older;
- smoke at least five cigarettes daily for the past year;
- not interested in quitting smoking in the next 6 months;
- Willing to use e-cigarettes;
Key exclusion criteria (4 listed)
- Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes;
- participation in a smoking cessation program in the past 30 days;
- pregnant or nursing.
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-Cig Zero NicotineE-Cig Zero Nicotine | Device | E-Cig Zero Nicotine |
| E-Cig 24mg NicotineE-Cig 24mg Nicotine | Device | E-Cig 24mg Nicotine |
Primary outcome
Change in Biomarker Concentrations: Nicotine Equivalents
Time frame: Baseline, Week 6
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Change in Biomarker Concentrations: NNAL
Time frame: Baseline, Week 6
Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34669956Okuyemi KS, Ojo-Fati O, Aremu TO, Friedrichsen SC, Grude L, Oyenuga M, Shyne M, Murphy SE, Hatsukami D, Joseph AM. A Randomized Trial of Nicotine versus No-nicotine E-cigarettes Among African American Smokers: Changes in Smoking and Tobacco Biomarkers. Nicotine Tob Res. 2022 Mar 1;24(4):555-563. doi: 10.1093/ntr/ntab212.
- Individual participant dataSharing planned: No
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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.
Anne Joseph, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Cig Zero Nicotine and E-Cig 24mg Nicotine in people with Biomarkers, run by University of Minnesota at 1 site 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 7 inclusion and 4 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 20 Mar 2020). 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?
Change in Biomarker Concentrations: Nicotine Equivalents (time frame: Baseline, Week 6). The study lists 2 primary outcomes in all. 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 NCT03084315, which also lists 1 linked publication.
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 26 Aug 2021.