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NCT04238832 · ClinicalTrials.gov registry record · NA

Salt-Based E-cigarette

A NA study of Smoking and Tobacco Use, sponsored by Medical University of South Carolina.

Completed
Registry status
NA
Development phase
24
Enrollment target
1
Study location

NCT04238832 is a NA study of Smoking and Tobacco Use that has completed, run by Medical University of South Carolina. The registered enrollment target is 24 participants, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04238832, a NA study of Smoking and Tobacco Use, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
NA
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home 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.

Conditions Studied

Interventions

  • OTHER Salt Base Nicotine
  • OTHER Free Base Nicotine

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-06-16
Est. Completion 2021-07-23
Phase NA

What the Registry Record Tells You About NCT04238832

The ClinicalTrials.gov registry entry for NCT04238832 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (95% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Smoking appearing as the primary indexed condition, and to 2 interventions - of which Salt Base Nicotine is the first listed.

NCT04238832 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT04238832 about?

NCT04238832 is a clinical study titled "Salt-Based E-cigarette". Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids...

What is the current status of trial NCT04238832?

This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2020-06-16. Estimated completion is 2021-07-23.

What conditions does trial NCT04238832 study?

This clinical trial studies the following conditions: Smoking, Tobacco Use.

What interventions are being tested in trial NCT04238832?

The interventions under investigation include: Salt Base Nicotine (OTHER), Free Base Nicotine (OTHER).

Who is sponsoring clinical trial NCT04238832?

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

Where is trial NCT04238832 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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