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NCT06602492
Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids
EARLY_PHASE1 trial testing Lower nicotine e-liquid in Healthy in 72 participants. Completed in 15 November 2023.
15 November 2023
Quick facts
| Lead sponsor | Rochester Institute of Technology |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 15 July 2021 |
| Primary completion | 15 November 2023 |
| Estimated completion | 15 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lower nicotine e-liquid — full drug profile →
- Higher nicotine eliquid — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
- Nicotine Addiction — all drugs for Nicotine Addiction →
- Electronic Cigarette Use — all drugs for Electronic Cigarette Use →
Sponsor
Rochester Institute of Technology
Who can join
21 and older, any sex, with Healthy or Nicotine Addiction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn if low nicotine eliquids work to reduce exposure to nicotine, in addicted ecig users, without increasing consumption of other harmful constituents. The main questions it aims to answer are: * Does switching to lower nicotine eliquids change the vaping behavior of addicted ecig users? * Does switching to lower nicotine eliquids reduce the amount of nicotine consumed? Researchers will compare ecig users who switch from a higher to lower nicotine eliquid to a control group that does not switch. Participants will: * Complete history of tobacco use and nicotine addiction questionnaires * Switch from higher to lower nicotine product or control for 15 days * Complete daily questionnaires to report craving, mood and nicotine withdraw For one full day under each nicotine condition, participants will: * record puffing behavior using a topography monitor * wear a sensorized shirt that measures the depth and duration of inhalation, and * collect a saliva sample at the end of each day
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06602492
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Rochester Institute of Technology trials
Trials by the same sponsor.
- NCT06619964 — Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids · enrolling by invitation
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 NCT06602492 (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: 27 September 2024
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/NCT06602492.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing