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NCT04357379 · ClinicalTrials.gov registry record · NA

IQOS (Non-Cigarette Tobacco Product) Pilot Study

A NA study, sponsored by Medical University of South Carolina.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT04357379 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 10 participants.

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The verdict

NCT04357379, a NA study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.

Interventions

  • BEHAVIORAL IQOS

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-07-23
Est. Completion 2020-10-22
Phase NA

What the Registry Record Tells You About NCT04357379

The ClinicalTrials.gov registry entry for NCT04357379 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 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 0 conditions, and to 1 intervention - of which IQOS is the first listed.

NCT04357379 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04357379 about?

NCT04357379 is a clinical study titled "IQOS (Non-Cigarette Tobacco Product) Pilot Study". A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS pro...

What is the current status of trial NCT04357379?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2020-07-23. Estimated completion is 2020-10-22.

What interventions are being tested in trial NCT04357379?

The interventions under investigation include: IQOS (BEHAVIORAL).

Who is sponsoring clinical trial NCT04357379?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.