Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids

NCT06619964 | Enrolling By Invitation

• 2 other identifiers: 1R01DA0576871R01DA057687-01A1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Addiction

Keywords

electronic cigarettes; nicotine addiction; eliquid nicotine concentration; perception of risk; health effects; biomarkers of exposure; subjective affect

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of observation at 2 weeks.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residence of the Greater Rochester, NY area

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rochester Institute of Technology: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Rochester: collaborator

Study Sites (1)

Rochester Institute of Technology

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 1, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)