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NCT06619964
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
trial in Nicotine Addiction in 120 participants. Enrolling by invitation.
28 February 2029
Quick facts
| Lead sponsor | Rochester Institute of Technology |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 5 November 2024 |
| Primary completion | 28 February 2029 |
| Estimated completion | 28 February 2029 |
| Sites | 1 location across United States |
Conditions studied
- Nicotine Addiction — all drugs for Nicotine Addiction →
Sponsor
Rochester Institute of Technology
Who can join
21 and older, any sex, with Nicotine Addiction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06619964
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Rochester Institute of Technology trials
Trials by the same sponsor.
- NCT06602492 — Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids · EARLY_PHASE1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06619964 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rochester Institute of Technology
- Last refreshed: 15 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06619964.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing