Nicotine AddictionNCT06619964
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
An observational study of Nicotine Addiction, run by Rochester Institute of Technology at 1 site in United States.
Trial summary
The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nicotine Addiction
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Residence of the Greater Rochester, NY area
Who may be able to join
- Age 21 yrs or older
- Pod-style or pen-style users, not adjustable for power or airflow, nicotine greater than 0 mg/mL
- Current everyday users
- Use history of at least 30 days
- No current use of combustible tobacco product, or nicotine replacement therapy
- CO less than 6 ppm at intake
- No plans to quit tobacco use in the next 30 days
Who cannot join
- History of acute or chronic asthma
- Previous diagnosis of cancer
- Other chronic medical conditions
- Use of chronic prescription medications
- Pneumonia in prior six weeks
- Upper respiratory tract infection or other febrile illness in previous 2 weeks
- On antioxidants or anti-inflammatory therapy
- Pregnant women or women who intend to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rochester Institute of Technology
Rochester, New York, 14623
About this study
The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids.
The main questions it aims to answer are:
Read more
- Do lower nicotine users actually consume less nicotine compared to higher nicotine users?
- Do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users?
- Do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? Researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect.
Participants will:
- Complete surveys on history of tobacco use, nicotine dependence and perception.
- Use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment.
- Complete daily questionnaires for mood and craving for two weeks in their natural environment.
- Collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment.
- Use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment.
- Provide saliva, urine and blood samples in the lab at the end of each week.
- Conditions
- Nicotine Addiction
- Keywords
- electronic cigarettes, nicotine addiction, eliquid nicotine concentration, perception of risk, health effects, biomarkers of exposure, subjective affect
- Medical subject headings
- Tobacco Use Disorder, Vaping
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily salivary cotinine
Nicotine exposure as indicated by mean daily salivary cotinine will be compared for lower versus higher nicotine strength regular ecig users, on a continuous scale. This will determine the extent to which reduced nicotine products result in lower nicotine exposure.
Measured: From enrollment to the end of observation at 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start5 Nov 2024
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rochester Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Rochester
- Responsible party
- Principal investigator, Risa Robinson, Rochester Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619964
- Sponsor's protocol ID
- 1R01DA057687
- Other IDs
- 1R01DA057687-01A1
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
- ClinicalTrials.gov ID
- NCT06619964
- Acronym / sponsor ID
- 1R01DA057687
- Conditions
- Nicotine Addiction
- Keywords
- electronic cigarettes, nicotine addiction, eliquid nicotine concentration, perception of risk, health effects, biomarkers of exposure, subjective affect
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rochester Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Rochester
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids.
The main questions it aims to answer are:
- Do lower nicotine users actually consume less nicotine compared to higher nicotine users?
- Do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users?
- Do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? Researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect.
Participants will:
- Complete surveys on history of tobacco use, nicotine dependence and perception.
- Use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment.
- Complete daily questionnaires for mood and craving for two weeks in their natural environment.
- Collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment.
- Use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment.
- Provide saliva, urine and blood samples in the lab at the end of each week.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residence of the Greater Rochester, NY area
Key inclusion criteria (7 listed)
- Age 21 yrs or older
- Pod-style or pen-style users, not adjustable for power or airflow, nicotine greater than 0 mg/mL
- Current everyday users
- Use history of at least 30 days
- No current use of combustible tobacco product, or nicotine replacement therapy
Key exclusion criteria (8 listed)
- History of acute or chronic asthma
- Previous diagnosis of cancer
- Other chronic medical conditions
- Use of chronic prescription medications
- Pneumonia in prior six weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean daily salivary cotinine
Time frame: From enrollment to the end of observation at 2 weeks.
Nicotine exposure as indicated by mean daily salivary cotinine will be compared for lower versus higher nicotine strength regular ecig users, on a continuous scale. This will determine the extent to which reduced nicotine products result in lower nicotine exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Addiction, run by Rochester Institute of Technology 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 8 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: enrolling by invitation, as of the sponsor's last update on 15 Jan 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean daily salivary cotinine (time frame: From enrollment to the end of observation at 2 weeks.). 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 Jan 2026.