Smoking, CigarettePhase 1NCT04003805
Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users
A Phase 1 study testing Standardized Research E-cigarette (SREC) in people with Smoking, Cigarette, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse. In the environment of continuously changing e-cigarette market, SREC was developed as a model e-cigarette that will remain available for an… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- Standardized Research E-cigarette (SREC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 17 Sep 2026
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
- Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
- Biochemically confirmed regular smoking status by a NicAlert test level of 6;
- Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
- No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
- Subjects are in good physical health (no unstable medical condition);
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- Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
- Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
- Women who are not pregnant or nursing or planning to become pregnant;
- Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Who cannot join
- Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
- Currently using nicotine replacement or other tobacco cessation products;
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
- Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
- Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
- Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
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- Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
- Pregnant or breastfeeding;
- Failure to agree to take adequate protection to avoid becoming pregnant during the study;
- Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
- Systolic BP greater than or equal to 160 mm/hg
- Diastolic BP greater than or equal to 100 mm/hg
- Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
- Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
- Heart rate greater than or equal to 105 bpm
- Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
- Expired air carbon monoxide (CO) level greater than 80 ppm;
- Self-reported allergies to propylene glycol or vegetable glycerin;
- Adverse reactions when previously using electronic cigarettes;
- Household member enrolled in the study concurrently;
- Unable to read for comprehension or completion of study documents;
- Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse. In the environment of continuously changing e-cigarette market, SREC was developed as a model e-cigarette that will remain available for an extended period of time and can be used as a bridging element in various studies aimed at evaluating the value and limitations of e-cigarettes as tobacco risk reduction tools. Our overall goal is to generate initial reference data on chemical exposures and associated effects in smokers switching to SREC.
- Conditions
- Smoking, Cigarette
- Being tested
- Standardized Research E-cigarette (SREC)
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Research E-cigarette (SREC)Drug
Standardized Research E-cigarette (SREC): The device operates using a rechargeable 400 mAh lithium-ion battery and uses sealed disposable 1.9-mL pods with e-liquid containing 5% w/w nicotine. Flavors that will be available include tobacco, menthol, watermelon and blueberry. The device uses a battery that can be recharged via a micro USB port. The e-liquid and the aerosol are well-characterized in terms of chemical impurities and by-products (such as aldehydes), which are minimal.
| Study group | Role | What they receive |
|---|---|---|
| Switching from Smoking Cigarettes to SREC | Experimental | Not described Receives: Drug: Standardized Research E-cigarette (SREC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure Biomarkers: Cotinine
Cotinine (biomarker of nicotine) level after switching to SREC as percentage of baseline level
Measured: 6 weeks
Exposure Biomarkers: NNAL
Total NNAL level after switching to SREC as percentage of baseline level
Measured: 6 weeks
Exposure Biomarkers: CEMA
CEMA level after switching to SREC as percentage of baseline level
Measured: 6 weeks
Exposure Biomarkers: 3-HPMA
3-HPMA level after switching to SREC as percentage of baseline level
Measured: 6 weeks
Inflammatory Biomarkers
Urinary isoprostane level after switching to SREC as percentage of baseline level
Measured: 6 weeks
Salivary Biomarkers
Levels of NNN in saliva after switching to SREC
Measured: 6 weeks
Secondary outcomes (4)
Product Use
For SREC e-cigarettes, puffs per day will be assessed from the number of times the product was used and the number of puffs during each use, based on the Interactive Voice Response (IVR) system. Average number of puffs per day.
Measured: 42 days
Cigarette Avoidance
The number of cigarette avoidance days, defined as no tobacco cigarettes smoked in the past 24 hours based on IVR, and the rate of cigarette avoidance, calculated as the proportion of cigarette avoidance days out of the total number of days in the product use period (42 days for those who complete the study).
Measured: 42 days
Exposure Biomarkers: Total NNN
Urinary total NNN level (TSNA biomarker) after switching to SREC as percentage of baseline level
Measured: 1 Year
Biomarker of Effect: 8-oxo-dG DNA Adduct
Blood level of 8-oxo-dG DNA adduct after switching to SREC as percentage of baseline level
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start11 May 2022
- Primary completion31 May 2024
- Study completion17 Sep 2026
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.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Irina Stepanov, PhD, Principal investigator, University of Minnesota, Division of Environmental Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003805
- Sponsor's protocol ID
- 2018NTLS016
- Other IDs
- U01DA045523
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2019
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users
- ClinicalTrials.gov ID
- NCT04003805
- Acronym / sponsor ID
- 2018NTLS016
- Conditions
- Smoking, Cigarette
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse. In the environment of continuously changing e-cigarette market, SREC was developed as a model e-cigarette that will remain available for an extended period of time and can be used as a bridging element in various studies aimed at evaluating the value and limitations of e-cigarettes as tobacco risk reduction tools. Our overall goal is to generate initial reference data on chemical exposures and associated effects in smokers switching to SREC.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switching from Smoking Cigarettes to SREC | Experimental | Drug: Standardized Research E-cigarette (SREC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
- Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
- Biochemically confirmed regular smoking status by a NicAlert test level of 6;
- Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
- No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
Key exclusion criteria (23 listed)
- Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
- Currently using nicotine replacement or other tobacco cessation products;
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
- Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
- Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
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 |
|---|---|---|
| Standardized Research E-cigarette (SREC)Standardized Research E-cigarette (SREC): The device operates using a rechargeable 400 mAh lithium-ion battery and uses sealed disposable 1.9-mL pods with e-liquid containing 5% w/w nicotine. Flavors that will be available include tobacco, menthol, watermelon and blueberry. The device uses a battery that can be recharged via a micro USB port. The e-liquid and the aerosol are well-characterized in terms of chemical impurities and by-products (such as aldehydes), which are minimal. | Drug | Switching from Smoking Cigarettes to SREC |
Primary outcome
Exposure Biomarkers: Cotinine
Time frame: 6 weeks
Cotinine (biomarker of nicotine) level after switching to SREC as percentage of baseline level
Exposure Biomarkers: NNAL
Time frame: 6 weeks
Total NNAL level after switching to SREC as percentage of baseline level
Exposure Biomarkers: CEMA
Time frame: 6 weeks
CEMA level after switching to SREC as percentage of baseline level
Exposure Biomarkers: 3-HPMA
Time frame: 6 weeks
3-HPMA level after switching to SREC as percentage of baseline level
Inflammatory Biomarkers
Time frame: 6 weeks
Urinary isoprostane level after switching to SREC as percentage of baseline level
Salivary Biomarkers
Time frame: 6 weeks
Levels of NNN in saliva after switching to SREC
4 secondary outcomes
Product Use
Time frame: 42 days
Cigarette Avoidance
Time frame: 42 days
Exposure Biomarkers: Total NNN
Time frame: 1 Year
Biomarker of Effect: 8-oxo-dG DNA Adduct
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Irina Stepanov, PhD principal investigator
University of Minnesota, Division of Environmental Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Standardized Research E-cigarette (SREC) in people with Smoking, Cigarette, run by Masonic Cancer Center, 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 10 inclusion and 23 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 15 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). 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?
Exposure Biomarkers: Cotinine (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.