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NCT05896033 · ClinicalTrials.gov registry record · NA
Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
A NA study of Smoking Prevention and Control, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05896033 is a NA study of Smoking Prevention and Control that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 240 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05896033, a NA study of Smoking Prevention and Control, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.
Conditions Studied
Interventions
- BEHAVIORAL Non-Menthol Cigarettes
- BEHAVIORAL Tobacco Flavored E-cigarettes
- BEHAVIORAL Menthol Cigarettes
- BEHAVIORAL Menthol Flavored E-cigarettes
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05896033
The ClinicalTrials.gov registry entry for NCT05896033 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Smoking Prevention and Control appearing as the primary indexed condition, and to 4 interventions - of which Non-Menthol Cigarettes is the first listed.
NCT05896033 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT05896033 about?
NCT05896033 is a clinical study titled "Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes". In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well...
What is the current status of trial NCT05896033?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2023-10-23. Estimated completion is 2027-08-31.
What conditions does trial NCT05896033 study?
This clinical trial studies the following conditions: Smoking Prevention and Control.
What interventions are being tested in trial NCT05896033?
The interventions under investigation include: Non-Menthol Cigarettes (BEHAVIORAL), Tobacco Flavored E-cigarettes (BEHAVIORAL), Menthol Cigarettes (BEHAVIORAL), Menthol Flavored E-cigarettes (BEHAVIORAL).
Who is sponsoring clinical trial NCT05896033?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05896033 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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