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NCT04003805 · ClinicalTrials.gov registry record · Phase 1
Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users
A Phase 1 study of Smoking, Cigarette, sponsored by Masonic Cancer Center, University of Minnesota.
- Active
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT04003805: Active Phase 1 study of Smoking, Cigarette, sponsored by Masonic Cancer Center, University of Minnesota.
NCT04003805 is a Phase 1 study of Smoking, Cigarette that is active but no longer recruiting, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 47 participants, below the 532-participant average among 21 other Smoking, Cigarette trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003805, a Phase 1 study of Smoking, Cigarette, is active but no longer recruiting, sponsored by Masonic Cancer Center, University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
Cotinine (biomarker of nicotine) level after switching to SREC as percentage of baseline level
Conditions Studied
Interventions
- DRUG Standardized Research E-cigarette (SREC)
Study Locations (1)
Minnesota
- University of Minnesota, Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2022-05-11 |
| Est. Completion | 2026-05-20 |
| Phase | Phase 1 |
What the registry record for NCT04003805 still lists
NCT04003805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 532-participant average among 21 other Smoking, Cigarette trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Smoking, Cigarette appearing as the primary indexed condition, and to 1 intervention - of which Standardized Research E-cigarette (SREC) is the first listed.
NCT04003805 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04003805 about?
NCT04003805 is a clinical study titled "Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users". 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 a...
What is the current status of trial NCT04003805?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2022-05-11. Estimated completion is 2026-05-20.
What conditions does trial NCT04003805 study?
This clinical trial studies the following conditions: Smoking, Cigarette.
What interventions are being tested in trial NCT04003805?
The interventions under investigation include: Standardized Research E-cigarette (SREC) (DRUG).
Who is sponsoring clinical trial NCT04003805?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04003805 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking, Cigarette
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04003805's enrollment target sits among peer trials
47 19th of 21 higher than 3 of 21 other Smoking, Cigarette trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking, Cigarette trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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