Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Aug 20, 2026 to Sep 17, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints revised (4)
  2. Study completion pushed from May 20, 2026 to Aug 20, 2026v20
  3. Results first posted: Jan 29, 2026v19 Show 9 more changesShow less
    • Primary endpoints: 11 to 6
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 125 to confirmed 47
    • Primary completion date changed from estimate of Jul 19, 2025 to May 31, 2024
    • Study completion date: Jan 20, 2026 to May 20, 2026
    • Interventions: Nicotine Mini-Lozenge (Drug), Standardized Research E-cigarette (SREC) (Drug) to Standardized Research E-cigarette (SREC) (Drug)
    • Secondary endpoints: 7 to 4
    • Site details revised
    • Study arms: 3 to 1
  4. Primary completion date: Jul 19, 2024 to Jul 19, 2025
    • Study completion date: Jan 20, 2025 to Jan 20, 2026
    v18
  5. Re-verified, no change to tracked fieldsv17
Show 15 earlier versionsHide 15 earlier versions
  1. Primary completion date: Dec 19, 2023 to Jul 19, 2024
    • Study completion date: Jan 20, 2024 to Jan 20, 2025
    v16
  2. Primary completion date: Jul 19, 2023 to Dec 19, 2023
    • Study completion date: Sep 20, 2023 to Jan 20, 2024
    v15
  3. Primary completion date: Sep 15, 2022 to Jul 19, 2023
    • Study completion date: Jan 15, 2023 to Sep 20, 2023
    v14
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2022 to May 11, 2022
    v13
  5. Start date: Mar 2022 to Jun 2022v12
  6. Start date: Dec 2021 to Mar 2022v11
  7. Start date: Aug 2021 to Dec 2021v10
  8. Start date: Feb 2021 to Aug 2021v9
  9. Primary completion date: Sep 15, 2021 to Sep 15, 2022
    • Start date: Nov 2020 to Feb 2021
    • Study completion date: Jan 15, 2022 to Jan 15, 2023
    v8
  10. Start date: Jul 2020 to Nov 2020v7
  11. Start date: Feb 2020 to Jul 2020v6
  12. Start date: Oct 2019 to Feb 2020v5
  13. Start date: Aug 2019 to Oct 2019
    • Primary completion date: Jul 15, 2021 to Sep 15, 2021
    • Study completion date: Nov 15, 2021 to Jan 15, 2022
    v4
  14. Primary endpoints: 6 to 11v3
  15. Primary endpoints revised (6)v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04003805
Lead Sponsor Masonic Cancer Center, University of Minnesota
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Smoking, Cigarette
Related terms Cigarette Smoking
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov